{
    "info": {
        "nct_id": "NCT06748872",
        "official_title": "EPITOME-1015-I: a Phase I Study to Investigate the Safety, Tolerability and Preliminary Efficacy of a Third Generation TCR-T Therapy, MDG1015, in Epithelial Ovarian Carcinoma, Gastroesophageal (Junction) Adenocarcinoma, Myxoid (Round Cell) Liposarcoma And/or Synovial Sarcoma Subjects with Advanced Disease Expressing NY-ESO-1 And/or LAGE-1a",
        "inclusion_criteria": "1. Adult, ≥ 18 years of age and weigh ≥ 40 kg for Dose levels 1-3 and ≥ 50 kg for Dose level 4\n2. Subject must have a confirmed diagnosis of either High grade serous or endometrioid ovarian, primary peritoneal or fallopian tube cancer Gastric or esophageal (junction) adenocarcinoma Myxoid (round cell) liposarcoma Synovial sarcoma\n3. Subject's must have tested positive for HLA-A*02:01 genotype by a Sponsor designated central laboratory\n4. Subject's tumor must have tested positive for NY-ESO-1 and/or LAGE-1a mRNA expression by a Sponsor designated central laboratory Both ≤1 year old archival tissue or fresh biopsy are allowed\n5. Subjects diagnosed with an eligible indication must have exhausted treatment options with proven survival benefit\n6. Subjects must have\n\n   1. measurable disease\n   2. Life expectancy ≥ 3 months per Investigator's opinion\n\n8. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 9. Adequate vital organ function 10. Adequate bone marrow function 11. Adequate coagulation profile 12. Toxicities from prior/ongoing therapies must have recovered to ≤ Grade 2 according to the CTCAE v5.0 or Subject's baseline excluding alopecia 14. Prior toxicities related to surgical procedures should have recovered to Grade ≤ 1 15. Women of childbearing potential (WCBP) or men who can father children must be willing and able to use adequate (e.g. barrier or licensed hormonal methods)\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Any uncontrolled medical or psychiatric disorder that would preclude participation as outlined\n2. HLA-A*02:02 or HLA-A*02:03 genotype\n3. Pregnant or lactating women\n4. Viral serology:\n\n   1. Known infection with HIV-1/2, CMV (CMV required only for U.S. sites) or HTLV-1/2,\n   2. Active infection with HBV or HCV\n   3. Positive test for Mycoplasma or Treponema Pallidum\n5. Uncontrolled infection(s) requiring intravenous anti-bacterial, anti-viral or anti-fungal treatment within 14 days prior to the first dose of LDC (patients receiving prophylactic antibiotics are eligible)\n6. Inadequate venous access for or contraindications to leukapheresis\n7. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to MDG1015 excipients, LDC agents, rasburicase, methylprednisolone or tocilizumab.\n8. Untreated CNS metastases or active CNS metastases (progressing or requiring corticosteroids for symptoms control) and leptomeningeal disease\n9. Unstable/active ulcer, varices, or digestive tract bleeding or recent digestive surgery that may have increased risk of bleeding\n10. History of another primary malignancy that requires intervention beyond surveillance or that has not been in remission for at least 1 year. The following are exempt from the 1-year limit:\n\n    1. non-melanoma skin cancer\n    2. curatively treated localized prostate cancer\n    3. carcinoma in situ (e.g. cervix, bladder, breast)\n11. NYHA Class ≥ II, heart failure, unstable angina, a history of recent (≤ 6 months) arrythmias, myocardial infarction or sustained (> 30 seconds) ventricular tachyarrhythmias\n12. Subjects who are dependent on dialysis\n13. Subjects with a history of pulmonary embolism or deep vein thrombosis that cannot safely withhold anti-coagulant therapy from leukapheresis until 7 days after administration of MDG1015 as determined by the Investigator\n14. Active autoimmune disease requiring systemic therapy except for adequately controlled Type 1 diabetes mellitus, autoimmune hypothyroidism or Grave's disease\n15. Previous allogeneic hematopoietic stem cell transplant within the last 5 years or solid organ transplant\n\n    Specific to GAC/GEJ Subjects:\n16. Positive history of esophageal or gastric resection that the Investigator considers is at increased risk of bleeding or perforation",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Adult, ≥ 18 years of age and weigh ≥ 40 kg for Dose levels 1-3 and ≥ 50 kg for Dose level 4",
                "criterions": [
                    {
                        "exact_snippets": "Adult, ≥ 18 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "weigh ≥ 40 kg for Dose levels 1-3",
                        "criterion": "weight",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "unit": "kg"
                            }
                        }
                    },
                    {
                        "exact_snippets": "weigh ... ≥ 50 kg for Dose level 4",
                        "criterion": "weight",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "kg"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Adult, ≥ 18 years of age",
                                "criterion": "age",
                                "requirement": {
                                    "requirement_type": "minimum",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "weigh ≥ 40 kg for Dose levels 1-3",
                                        "criterion": "weight",
                                        "requirement": {
                                            "requirement_type": "minimum",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 40,
                                                "unit": "kg"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "weigh ... ≥ 50 kg for Dose level 4",
                                        "criterion": "weight",
                                        "requirement": {
                                            "requirement_type": "minimum",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 50,
                                                "unit": "kg"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Subject must have a confirmed diagnosis of either High grade serous or endometrioid ovarian, primary peritoneal or fallopian tube cancer Gastric or esophageal (junction) adenocarcinoma Myxoid (round cell) liposarcoma Synovial sarcoma",
                "criterions": [
                    {
                        "exact_snippets": "confirmed diagnosis of either High grade serous or endometrioid ovarian, primary peritoneal or fallopian tube cancer",
                        "criterion": "cancer type",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": [
                                "High grade serous ovarian cancer",
                                "endometrioid ovarian cancer",
                                "primary peritoneal cancer",
                                "fallopian tube cancer"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "confirmed diagnosis of ... Gastric or esophageal (junction) adenocarcinoma",
                        "criterion": "cancer type",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": [
                                "Gastric adenocarcinoma",
                                "esophageal (junction) adenocarcinoma"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "confirmed diagnosis of ... Myxoid (round cell) liposarcoma",
                        "criterion": "cancer type",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": "Myxoid (round cell) liposarcoma"
                        }
                    },
                    {
                        "exact_snippets": "confirmed diagnosis of ... Synovial sarcoma",
                        "criterion": "cancer type",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": "Synovial sarcoma"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "confirmed diagnosis of either High grade serous or endometrioid ovarian, primary peritoneal or fallopian tube cancer",
                                "criterion": "cancer type",
                                "requirement": {
                                    "requirement_type": "diagnosis",
                                    "expected_value": [
                                        "High grade serous ovarian cancer",
                                        "endometrioid ovarian cancer",
                                        "primary peritoneal cancer",
                                        "fallopian tube cancer"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "confirmed diagnosis of ... Gastric or esophageal (junction) adenocarcinoma",
                                "criterion": "cancer type",
                                "requirement": {
                                    "requirement_type": "diagnosis",
                                    "expected_value": [
                                        "Gastric adenocarcinoma",
                                        "esophageal (junction) adenocarcinoma"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "confirmed diagnosis of ... Myxoid (round cell) liposarcoma",
                                "criterion": "cancer type",
                                "requirement": {
                                    "requirement_type": "diagnosis",
                                    "expected_value": "Myxoid (round cell) liposarcoma"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "confirmed diagnosis of ... Synovial sarcoma",
                                "criterion": "cancer type",
                                "requirement": {
                                    "requirement_type": "diagnosis",
                                    "expected_value": "Synovial sarcoma"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Subject's must have tested positive for HLA-A*02:01 genotype by a Sponsor designated central laboratory",
                "criterions": [
                    {
                        "exact_snippets": "tested positive for HLA-A*02:01 genotype",
                        "criterion": "HLA-A*02:01 genotype",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "by a Sponsor designated central laboratory",
                        "criterion": "testing location",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "Sponsor designated central laboratory"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "tested positive for HLA-A*02:01 genotype",
                        "criterion": "HLA-A*02:01 genotype",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "by a Sponsor designated central laboratory",
                        "criterion": "testing location",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "Sponsor designated central laboratory"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Subject's tumor must have tested positive for NY-ESO-1 and/or LAGE-1a mRNA expression by a Sponsor designated central laboratory Both ≤1 year old archival tissue or fresh biopsy are allowed",
                "criterions": [
                    {
                        "exact_snippets": "Subject's tumor must have tested positive for NY-ESO-1",
                        "criterion": "NY-ESO-1 mRNA expression",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Subject's tumor must have tested positive for ... LAGE-1a mRNA expression",
                        "criterion": "LAGE-1a mRNA expression",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Both ≤1 year old archival tissue or fresh biopsy are allowed",
                        "criterion": "tissue age",
                        "requirement": {
                            "requirement_type": "age",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "year"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Subject's tumor must have tested positive for NY-ESO-1",
                                        "criterion": "NY-ESO-1 mRNA expression",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "Both ≤1 year old archival tissue or fresh biopsy are allowed",
                                        "criterion": "tissue age",
                                        "requirement": {
                                            "requirement_type": "age",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": "<=",
                                                        "value": 1,
                                                        "unit": "year"
                                                    }
                                                ]
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Subject's tumor must have tested positive for ... LAGE-1a mRNA expression",
                                        "criterion": "LAGE-1a mRNA expression",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "Both ≤1 year old archival tissue or fresh biopsy are allowed",
                                        "criterion": "tissue age",
                                        "requirement": {
                                            "requirement_type": "age",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": "<=",
                                                        "value": 1,
                                                        "unit": "year"
                                                    }
                                                ]
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Subjects diagnosed with an eligible indication must have exhausted treatment options with proven survival benefit",
                "criterions": [
                    {
                        "exact_snippets": "Subjects diagnosed with an eligible indication",
                        "criterion": "eligible indication diagnosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "must have exhausted treatment options with proven survival benefit",
                        "criterion": "treatment options with proven survival benefit",
                        "requirement": {
                            "requirement_type": "exhaustion",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Subjects diagnosed with an eligible indication",
                        "criterion": "eligible indication diagnosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "must have exhausted treatment options with proven survival benefit",
                        "criterion": "treatment options with proven survival benefit",
                        "requirement": {
                            "requirement_type": "exhaustion",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. measurable disease",
                "criterions": [
                    {
                        "exact_snippets": "measurable disease",
                        "criterion": "disease",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "measurable disease",
                        "criterion": "disease",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Life expectancy ≥ 3 months per Investigator's opinion",
                "criterions": [
                    {
                        "exact_snippets": "Life expectancy ≥ 3 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Life expectancy ≥ 3 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "per Investigator's opinion",
                        "criterion": "Investigator's opinion on life expectancy",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 9. Adequate vital organ function 10. Adequate bone marrow function 11. Adequate coagulation profile 12. Toxicities from prior/ongoing therapies must have recovered to ≤ Grade 2 according to the CTCAE v5.0 or Subject's baseline excluding alopecia 14. Prior toxicities related to surgical procedures should have recovered to Grade ≤ 1 15. Women of childbearing potential (WCBP) or men who can father children must be willing and able to use adequate (e.g. barrier or licensed hormonal methods)",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0-1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Adequate vital organ function",
                        "criterion": "vital organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate bone marrow function",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate coagulation profile",
                        "criterion": "coagulation profile",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Toxicities from prior/ongoing therapies must have recovered to ≤ Grade 2 according to the CTCAE v5.0",
                        "criterion": "toxicities from prior/ongoing therapies",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Prior toxicities related to surgical procedures should have recovered to Grade ≤ 1",
                        "criterion": "toxicities related to surgical procedures",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Women of childbearing potential (WCBP) or men who can father children must be willing and able to use adequate (e.g. barrier or licensed hormonal methods)",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "willingness and ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0-1",
                                "criterion": "ECOG performance status",
                                "requirement": {
                                    "requirement_type": "range",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": ">=",
                                                "value": 0,
                                                "unit": "N/A"
                                            },
                                            {
                                                "operator": "<=",
                                                "value": 1,
                                                "unit": "N/A"
                                            }
                                        ]
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Adequate vital organ function",
                                "criterion": "vital organ function",
                                "requirement": {
                                    "requirement_type": "adequacy",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Adequate bone marrow function",
                                "criterion": "bone marrow function",
                                "requirement": {
                                    "requirement_type": "adequacy",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Adequate coagulation profile",
                                "criterion": "coagulation profile",
                                "requirement": {
                                    "requirement_type": "adequacy",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Toxicities from prior/ongoing therapies must have recovered to ≤ Grade 2 according to the CTCAE v5.0",
                                "criterion": "toxicities from prior/ongoing therapies",
                                "requirement": {
                                    "requirement_type": "recovery",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "Grade"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Prior toxicities related to surgical procedures should have recovered to Grade ≤ 1",
                                "criterion": "toxicities related to surgical procedures",
                                "requirement": {
                                    "requirement_type": "recovery",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "Grade"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Women of childbearing potential (WCBP) or men who can father children must be willing and able to use adequate (e.g. barrier or licensed hormonal methods)",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "willingness and ability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Subjects must have",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. Any uncontrolled medical or psychiatric disorder that would preclude participation as outlined",
                "criterions": [
                    {
                        "exact_snippets": "uncontrolled medical or psychiatric disorder",
                        "criterion": "uncontrolled medical disorder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled medical or psychiatric disorder",
                        "criterion": "uncontrolled psychiatric disorder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "uncontrolled medical or psychiatric disorder",
                        "criterion": "uncontrolled medical disorder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled medical or psychiatric disorder",
                        "criterion": "uncontrolled psychiatric disorder",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. HLA-A*02:02 or HLA-A*02:03 genotype",
                "criterions": [
                    {
                        "exact_snippets": "HLA-A*02:02",
                        "criterion": "HLA genotype",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "HLA-A*02:02"
                        }
                    },
                    {
                        "exact_snippets": "HLA-A*02:03 genotype",
                        "criterion": "HLA genotype",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "HLA-A*02:03"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "HLA-A*02:02",
                        "criterion": "HLA genotype",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "HLA-A*02:02"
                        }
                    },
                    {
                        "exact_snippets": "HLA-A*02:03 genotype",
                        "criterion": "HLA genotype",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "HLA-A*02:03"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Viral serology:",
                "criterions": [
                    {
                        "exact_snippets": "Viral serology",
                        "criterion": "viral serology",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Viral serology",
                    "criterion": "viral serology",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "1. Known infection with HIV-1/2, CMV (CMV required only for U.S. sites) or HTLV-1/2,",
                "criterions": [
                    {
                        "exact_snippets": "Known infection with HIV-1/2",
                        "criterion": "HIV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Known infection with ... CMV (CMV required only for U.S. sites)",
                        "criterion": "CMV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Known infection with ... HTLV-1/2",
                        "criterion": "HTLV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Known infection with HIV-1/2",
                                        "criterion": "HIV infection",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "Known infection with ... HTLV-1/2",
                                        "criterion": "HTLV infection",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Known infection with ... CMV (CMV required only for U.S. sites)",
                                "criterion": "CMV infection",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Active infection with HBV or HCV",
                "criterions": [
                    {
                        "exact_snippets": "Active infection with HBV",
                        "criterion": "HBV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Active infection with ... HCV",
                        "criterion": "HCV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Active infection with HBV",
                        "criterion": "HBV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Active infection with ... HCV",
                        "criterion": "HCV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Positive test for Mycoplasma or Treponema Pallidum",
                "criterions": [
                    {
                        "exact_snippets": "Positive test for Mycoplasma",
                        "criterion": "Mycoplasma",
                        "requirement": {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "Positive test for ... Treponema Pallidum",
                        "criterion": "Treponema Pallidum",
                        "requirement": {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Positive test for Mycoplasma",
                        "criterion": "Mycoplasma",
                        "requirement": {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "Positive test for ... Treponema Pallidum",
                        "criterion": "Treponema Pallidum",
                        "requirement": {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Uncontrolled infection(s) requiring intravenous anti-bacterial, anti-viral or anti-fungal treatment within 14 days prior to the first dose of LDC (patients receiving prophylactic antibiotics are eligible)",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled infection(s) requiring intravenous anti-bacterial, anti-viral or anti-fungal treatment within 14 days prior to the first dose of LDC",
                        "criterion": "uncontrolled infection",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "intravenous anti-bacterial",
                                "anti-viral",
                                "anti-fungal"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled infection(s) requiring intravenous anti-bacterial, anti-viral or anti-fungal treatment within 14 days prior to the first dose of LDC",
                        "criterion": "uncontrolled infection",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 14 days prior to the first dose of LDC"
                        }
                    },
                    {
                        "exact_snippets": "patients receiving prophylactic antibiotics are eligible",
                        "criterion": "prophylactic antibiotics",
                        "requirement": {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Uncontrolled infection(s) requiring intravenous anti-bacterial, anti-viral or anti-fungal treatment within 14 days prior to the first dose of LDC",
                                    "criterion": "uncontrolled infection",
                                    "requirement": {
                                        "requirement_type": "treatment",
                                        "expected_value": [
                                            "intravenous anti-bacterial",
                                            "anti-viral",
                                            "anti-fungal"
                                        ]
                                    }
                                },
                                {
                                    "exact_snippets": "Uncontrolled infection(s) requiring intravenous anti-bacterial, anti-viral or anti-fungal treatment within 14 days prior to the first dose of LDC",
                                    "criterion": "uncontrolled infection",
                                    "requirement": {
                                        "requirement_type": "time frame",
                                        "expected_value": "within 14 days prior to the first dose of LDC"
                                    }
                                }
                            ]
                        },
                        {
                            "not_criteria": {
                                "exact_snippets": "patients receiving prophylactic antibiotics are eligible",
                                "criterion": "prophylactic antibiotics",
                                "requirement": {
                                    "requirement_type": "eligibility",
                                    "expected_value": true
                                }
                            }
                        }
                    ]
                },
                "then_criteria": null,
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "6. Inadequate venous access for or contraindications to leukapheresis",
                "criterions": [
                    {
                        "exact_snippets": "Inadequate venous access",
                        "criterion": "venous access",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "contraindications to leukapheresis",
                        "criterion": "leukapheresis",
                        "requirement": {
                            "requirement_type": "contraindications",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Inadequate venous access",
                        "criterion": "venous access",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "contraindications to leukapheresis",
                        "criterion": "leukapheresis",
                        "requirement": {
                            "requirement_type": "contraindications",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to MDG1015 excipients, LDC agents, rasburicase, methylprednisolone or tocilizumab.",
                "criterions": [
                    {
                        "exact_snippets": "Contraindications or life-threatening allergies, hypersensitivity, or intolerance to MDG1015 excipients",
                        "criterion": "allergy or intolerance to MDG1015 excipients",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Contraindications or life-threatening allergies, hypersensitivity, or intolerance to ... LDC agents",
                        "criterion": "allergy or intolerance to LDC agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Contraindications or life-threatening allergies, hypersensitivity, or intolerance to ... rasburicase",
                        "criterion": "allergy or intolerance to rasburicase",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Contraindications or life-threatening allergies, hypersensitivity, or intolerance to ... methylprednisolone",
                        "criterion": "allergy or intolerance to methylprednisolone",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Contraindications or life-threatening allergies, hypersensitivity, or intolerance to ... tocilizumab",
                        "criterion": "allergy or intolerance to tocilizumab",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Contraindications or life-threatening allergies, hypersensitivity, or intolerance to MDG1015 excipients",
                        "criterion": "allergy or intolerance to MDG1015 excipients",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Contraindications or life-threatening allergies, hypersensitivity, or intolerance to ... LDC agents",
                        "criterion": "allergy or intolerance to LDC agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Contraindications or life-threatening allergies, hypersensitivity, or intolerance to ... rasburicase",
                        "criterion": "allergy or intolerance to rasburicase",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Contraindications or life-threatening allergies, hypersensitivity, or intolerance to ... methylprednisolone",
                        "criterion": "allergy or intolerance to methylprednisolone",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Contraindications or life-threatening allergies, hypersensitivity, or intolerance to ... tocilizumab",
                        "criterion": "allergy or intolerance to tocilizumab",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Untreated CNS metastases or active CNS metastases (progressing or requiring corticosteroids for symptoms control) and leptomeningeal disease",
                "criterions": [
                    {
                        "exact_snippets": "Untreated CNS metastases",
                        "criterion": "CNS metastases",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    },
                    {
                        "exact_snippets": "active CNS metastases (progressing or requiring corticosteroids for symptoms control)",
                        "criterion": "CNS metastases",
                        "requirement": {
                            "requirement_type": "activity status",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "active CNS metastases (progressing or requiring corticosteroids for symptoms control)",
                        "criterion": "CNS metastases",
                        "requirement": {
                            "requirement_type": "progression status",
                            "expected_value": "progressing"
                        }
                    },
                    {
                        "exact_snippets": "active CNS metastases (progressing or requiring corticosteroids for symptoms control)",
                        "criterion": "CNS metastases",
                        "requirement": {
                            "requirement_type": "corticosteroid requirement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "leptomeningeal disease",
                        "criterion": "leptomeningeal disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Untreated CNS metastases",
                                "criterion": "CNS metastases",
                                "requirement": {
                                    "requirement_type": "treatment status",
                                    "expected_value": "untreated"
                                }
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "active CNS metastases (progressing or requiring corticosteroids for symptoms control)",
                                        "criterion": "CNS metastases",
                                        "requirement": {
                                            "requirement_type": "activity status",
                                            "expected_value": "active"
                                        }
                                    },
                                    {
                                        "or_criteria": [
                                            {
                                                "exact_snippets": "active CNS metastases (progressing or requiring corticosteroids for symptoms control)",
                                                "criterion": "CNS metastases",
                                                "requirement": {
                                                    "requirement_type": "progression status",
                                                    "expected_value": "progressing"
                                                }
                                            },
                                            {
                                                "exact_snippets": "active CNS metastases (progressing or requiring corticosteroids for symptoms control)",
                                                "criterion": "CNS metastases",
                                                "requirement": {
                                                    "requirement_type": "corticosteroid requirement",
                                                    "expected_value": true
                                                }
                                            }
                                        ]
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "leptomeningeal disease",
                        "criterion": "leptomeningeal disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Unstable/active ulcer, varices, or digestive tract bleeding or recent digestive surgery that may have increased risk of bleeding",
                "criterions": [
                    {
                        "exact_snippets": "Unstable/active ulcer",
                        "criterion": "ulcer",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    },
                    {
                        "exact_snippets": "Unstable/active ulcer",
                        "criterion": "ulcer",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "varices",
                        "criterion": "varices",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "digestive tract bleeding",
                        "criterion": "digestive tract bleeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "recent digestive surgery",
                        "criterion": "digestive surgery",
                        "requirement": {
                            "requirement_type": "recency",
                            "expected_value": "recent"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Unstable/active ulcer",
                                        "criterion": "ulcer",
                                        "requirement": {
                                            "requirement_type": "stability",
                                            "expected_value": "unstable"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Unstable/active ulcer",
                                        "criterion": "ulcer",
                                        "requirement": {
                                            "requirement_type": "activity",
                                            "expected_value": "active"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "varices",
                                "criterion": "varices",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "digestive tract bleeding",
                                "criterion": "digestive tract bleeding",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "recent digestive surgery",
                        "criterion": "digestive surgery",
                        "requirement": {
                            "requirement_type": "recency",
                            "expected_value": "recent"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "10. History of another primary malignancy that requires intervention beyond surveillance or that has not been in remission for at least 1 year. The following are exempt from the 1-year limit:",
                "criterions": [
                    {
                        "exact_snippets": "History of another primary malignancy",
                        "criterion": "another primary malignancy",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "requires intervention beyond surveillance",
                        "criterion": "intervention requirement",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "beyond surveillance"
                        }
                    },
                    {
                        "exact_snippets": "has not been in remission for at least 1 year",
                        "criterion": "remission duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of another primary malignancy",
                                "criterion": "another primary malignancy",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "requires intervention beyond surveillance",
                                "criterion": "intervention requirement",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "beyond surveillance"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of another primary malignancy",
                                "criterion": "another primary malignancy",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "has not been in remission for at least 1 year",
                                "criterion": "remission duration",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 1,
                                        "unit": "year"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. non-melanoma skin cancer",
                "criterions": [
                    {
                        "exact_snippets": "non-melanoma skin cancer",
                        "criterion": "non-melanoma skin cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "non-melanoma skin cancer",
                    "criterion": "non-melanoma skin cancer",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "15. Previous allogeneic hematopoietic stem cell transplant within the last 5 years or solid organ transplant",
                "criterions": [
                    {
                        "exact_snippets": "Previous allogeneic hematopoietic stem cell transplant within the last 5 years",
                        "criterion": "allogeneic hematopoietic stem cell transplant",
                        "requirement": {
                            "requirement_type": "time since transplant",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "solid organ transplant",
                        "criterion": "solid organ transplant",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Previous allogeneic hematopoietic stem cell transplant within the last 5 years",
                                "criterion": "allogeneic hematopoietic stem cell transplant",
                                "requirement": {
                                    "requirement_type": "time since transplant",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "solid organ transplant",
                        "criterion": "solid organ transplant",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Specific to GAC/GEJ Subjects:",
                "criterions": [
                    {
                        "exact_snippets": "Specific to GAC/GEJ Subjects",
                        "criterion": "cancer type",
                        "requirement": {
                            "requirement_type": "specificity",
                            "expected_value": [
                                "Gastric Adenocarcinoma (GAC)",
                                "Gastroesophageal Junction (GEJ)"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Specific to GAC/GEJ Subjects",
                    "criterion": "cancer type",
                    "requirement": {
                        "requirement_type": "specificity",
                        "expected_value": [
                            "Gastric Adenocarcinoma (GAC)",
                            "Gastroesophageal Junction (GEJ)"
                        ]
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "16. Positive history of esophageal or gastric resection that the Investigator considers is at increased risk of bleeding or perforation",
                "criterions": [
                    {
                        "exact_snippets": "Positive history of esophageal or gastric resection",
                        "criterion": "esophageal or gastric resection",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "the Investigator considers is at increased risk of bleeding or perforation",
                        "criterion": "risk of bleeding or perforation",
                        "requirement": {
                            "requirement_type": "risk",
                            "expected_value": "increased"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": "Positive history of esophageal or gastric resection",
                            "criterion": "esophageal or gastric resection",
                            "requirement": {
                                "requirement_type": "history",
                                "expected_value": true
                            }
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