{
    "info": {
        "nct_id": "NCT06471673",
        "official_title": "A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer",
        "inclusion_criteria": "1. Histological confirmed recurrent metastatic breast cancer which has failed prior\n\n   therapy defined as:\n   1. Human epidermal growth factor 2 (EGFR2, HER2) positive tumors must have failed therapy with at least 2 anti-HER2 agents\n   2. HER2 negative and either ER or PR positive tumors: must be refractory to hormonal therapy and previously treated with at least 2 hormone based targeted therapy containing regimens.\n   3. Triple-negative and inflammatory tumors must have exhausted other curative intent therapies including prior treatment with a taxane and platinum-based agent\n   4. All other MBC types must have exhausted other curative intent therapies including any genomic or germline directed targeted therapy having available approved drug(s)\n   5. Patients with new or progressive breast cancer metastatic to the brain will be eligible, provided:\n\n   i. The brain metastases must be clinically stable (without evidence of progressive disease by imaging) for at least 4 weeks, prior to first dose.\n\n   ii. There is no need for steroids and patients have not had steroids for at least 2 weeks prior to the first dose.\n2. Be 18 years of age or older.\n3. Have expected survival of at least 4 months.\n4. Have adequate performance status (up to and including ECOG 2)\n5. Patients must be stable with all known or expected toxicities from previous treatment including:\n\n   1. Prior immune related toxicity must not have exceeded Grade 2 with exception of stable endocrinopathy (endocrinopathy if well-managed, is not exclusionary).\n   2. Toxicity of prior therapy that has not recovered to ≤ grade 1 or baseline (with the exception of any grade of alopecia, adequately treated endocrinopathy, and anemia not requiring transfusion support).\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Concurrent anti-cancer treatment.\n2. Recent chemotherapy, radiotherapy, or other anti-cancer treatment within 3 weeks of first protocol treatment.\n3. Participant has not recovered adequately from toxicities and/or complications from surgical intervention before starting study drug.\n4. History of clinical hypersensitivity to the designated therapy, as specified in the protocol or to any components used in the preparation of any cell line in this study.\n5. History of clinical hypersensitivity to any protocol specified therapy.\n6. BUN >30 in conjunction with a creatinine >2, or calculated creatinine clearance (CrCl) <30 mL/min (GFR can be used in place of creatinine or CrCl).\n7. Absolute granulocyte count < 1000; platelets <50,000.\n8. Bilirubin >2.0; alkaline phosphatase >4x upper limit of normal (ULN); ALT/AST >2x ULN. For patients with hepatic metastases, ALT/AST >5x ULN is exclusionary.\n9. Proteinuria >1+ on urinalysis or >1 gm/24hr.\n10. New York Heart Association stage 3 or 4 cardiac disease.\n11. A pleural or pericardial effusion of moderate severity or worse.\n12. Any woman of childbearing potential (i.e., has had a menstrual cycle within the past year and has not been surgically sterilized), unless she: agrees to take appropriate precautions to avoid becoming pregnant during the study and has a negative serum pregnancy test within 7 days prior to starting treatment.\n13. Men who are fertile/reproductively competent, should take appropriate precautions to avoid fathering a child for the duration of the study.\n14. Women who are pregnant or nursing.\n15. Patients with concurrent second malignancy.\n16. Persons with previous malignancies requiring treatment within the past 24 months.\n17. Patients who have clinical or laboratory features indicative of AIDS and are HIV positive (by self-report).\n18. Have a diagnosis of immunodeficiency, or is receiving chronic systemic steroid therapy (doses exceeding 10 mg daily of prednisone equivalent), or any other form of immunosuppressive therapy within 21 days prior to first dose of study treatment.\n19. Patients who are on treatment for an autoimmune disease, unless specifically approved by the Investigator and the Sponsor.\n20. Patients with severe psychiatric (e.g., schizophrenia, bipolar, or borderline personality disorder) or other clinically progressive major medical problems, unless approved by the Investigator and Sponsor.\n21. Patients may not be on a concurrent clinical trial, unless approved by Investigator and Sponsor.",
        "miscellaneous_criteria": "Key"
    },
    "inclusion_lines": [
        {
            "line": "1. Histological confirmed recurrent metastatic breast cancer which has failed prior",
            "criterions": [
                {
                    "exact_snippets": "Histological confirmed recurrent metastatic breast cancer",
                    "criterion": "recurrent metastatic breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histological"
                        }
                    ]
                },
                {
                    "exact_snippets": "failed prior",
                    "criterion": "prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "outcome",
                            "expected_value": "failed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "therapy defined as:",
            "criterions": [
                {
                    "exact_snippets": "therapy defined as:",
                    "criterion": "therapy",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Human epidermal growth factor 2 (EGFR2, HER2) positive tumors must have failed therapy with at least 2 anti-HER2 agents",
            "criterions": [
                {
                    "exact_snippets": "Human epidermal growth factor 2 (EGFR2, HER2) positive tumors",
                    "criterion": "HER2 positive tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have failed therapy with at least 2 anti-HER2 agents",
                    "criterion": "therapy failure with anti-HER2 agents",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "agents"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. HER2 negative and either ER or PR positive tumors: must be refractory to hormonal therapy and previously treated with at least 2 hormone based targeted therapy containing regimens.",
            "criterions": [
                {
                    "exact_snippets": "HER2 negative",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "ER or PR positive tumors",
                    "criterion": "ER or PR status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "ER positive",
                                "PR positive"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "must be refractory to hormonal therapy",
                    "criterion": "hormonal therapy response",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "refractory"
                        }
                    ]
                },
                {
                    "exact_snippets": "previously treated with at least 2 hormone based targeted therapy containing regimens",
                    "criterion": "hormone based targeted therapy regimens",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "regimens"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Triple-negative and inflammatory tumors must have exhausted other curative intent therapies including prior treatment with a taxane and platinum-based agent",
            "criterions": [
                {
                    "exact_snippets": "Triple-negative and inflammatory tumors",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "triple-negative",
                                "inflammatory"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "must have exhausted other curative intent therapies",
                    "criterion": "curative intent therapies",
                    "requirements": [
                        {
                            "requirement_type": "exhaustion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including prior treatment with a taxane",
                    "criterion": "taxane treatment",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including prior treatment with ... platinum-based agent",
                    "criterion": "platinum-based agent treatment",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. All other MBC types must have exhausted other curative intent therapies including any genomic or germline directed targeted therapy having available approved drug(s)",
            "criterions": [
                {
                    "exact_snippets": "All other MBC types must have exhausted other curative intent therapies",
                    "criterion": "MBC types",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "exhausted curative intent therapies"
                        }
                    ]
                },
                {
                    "exact_snippets": "including any genomic or germline directed targeted therapy having available approved drug(s)",
                    "criterion": "genomic or germline directed targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "exhausted"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients with new or progressive breast cancer metastatic to the brain will be eligible, provided:",
            "criterions": [
                {
                    "exact_snippets": "new or progressive breast cancer metastatic to the brain",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": [
                                "new",
                                "progressive"
                            ]
                        },
                        {
                            "requirement_type": "metastasis",
                            "expected_value": "brain"
                        }
                    ]
                }
            ]
        },
        {
            "line": "i. The brain metastases must be clinically stable (without evidence of progressive disease by imaging) for at least 4 weeks, prior to first dose.",
            "criterions": [
                {
                    "exact_snippets": "The brain metastases must be clinically stable (without evidence of progressive disease by imaging)",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "clinically stable"
                        },
                        {
                            "requirement_type": "progression",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "for at least 4 weeks, prior to first dose",
                    "criterion": "stability duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "ii. There is no need for steroids and patients have not had steroids for at least 2 weeks prior to the first dose.",
            "criterions": [
                {
                    "exact_snippets": "There is no need for steroids",
                    "criterion": "steroid need",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "patients have not had steroids for at least 2 weeks prior to the first dose",
                    "criterion": "steroid usage",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Be 18 years of age or older.",
            "criterions": [
                {
                    "exact_snippets": "18 years of age or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Have expected survival of at least 4 months.",
            "criterions": [
                {
                    "exact_snippets": "expected survival of at least 4 months",
                    "criterion": "expected survival",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Have adequate performance status (up to and including ECOG 2)",
            "criterions": [
                {
                    "exact_snippets": "adequate performance status (up to and including ECOG 2)",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "ECOG"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients must be stable with all known or expected toxicities from previous treatment including:",
            "criterions": [
                {
                    "exact_snippets": "stable with all known or expected toxicities from previous treatment",
                    "criterion": "toxicities from previous treatment",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Prior immune related toxicity must not have exceeded Grade 2 with exception of stable endocrinopathy (endocrinopathy if well-managed, is not exclusionary).",
            "criterions": [
                {
                    "exact_snippets": "Prior immune related toxicity must not have exceeded Grade 2",
                    "criterion": "immune related toxicity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "exception of stable endocrinopathy (endocrinopathy if well-managed, is not exclusionary)",
                    "criterion": "endocrinopathy",
                    "requirements": [
                        {
                            "requirement_type": "management",
                            "expected_value": "well-managed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Toxicity of prior therapy that has not recovered to ≤ grade 1 or baseline (with the exception of any grade of alopecia, adequately treated endocrinopathy, and anemia not requiring transfusion support).",
            "criterions": [
                {
                    "exact_snippets": "Toxicity of prior therapy that has not recovered to ≤ grade 1 or baseline",
                    "criterion": "toxicity of prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "grade"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alopecia",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated endocrinopathy",
                    "criterion": "endocrinopathy",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "anemia not requiring transfusion support",
                    "criterion": "anemia",
                    "requirements": [
                        {
                            "requirement_type": "transfusion support",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Concurrent anti-cancer treatment.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent anti-cancer treatment",
                    "criterion": "anti-cancer treatment",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Recent chemotherapy, radiotherapy, or other anti-cancer treatment within 3 weeks of first protocol treatment.",
            "criterions": [
                {
                    "exact_snippets": "Recent chemotherapy ... within 3 weeks of first protocol treatment.",
                    "criterion": "recent chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Recent ... radiotherapy ... within 3 weeks of first protocol treatment.",
                    "criterion": "recent radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Recent ... other anti-cancer treatment within 3 weeks of first protocol treatment.",
                    "criterion": "recent other anti-cancer treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Participant has not recovered adequately from toxicities and/or complications from surgical intervention before starting study drug.",
            "criterions": [
                {
                    "exact_snippets": "Participant has not recovered adequately from toxicities",
                    "criterion": "recovery from toxicities",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Participant has not recovered adequately from ... complications from surgical intervention",
                    "criterion": "recovery from complications from surgical intervention",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. History of clinical hypersensitivity to the designated therapy, as specified in the protocol or to any components used in the preparation of any cell line in this study.",
            "criterions": [
                {
                    "exact_snippets": "History of clinical hypersensitivity to the designated therapy",
                    "criterion": "clinical hypersensitivity to the designated therapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity ... to any components used in the preparation of any cell line in this study",
                    "criterion": "hypersensitivity to components used in cell line preparation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. History of clinical hypersensitivity to any protocol specified therapy.",
            "criterions": [
                {
                    "exact_snippets": "History of clinical hypersensitivity to any protocol specified therapy.",
                    "criterion": "clinical hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. BUN >30 in conjunction with a creatinine >2, or calculated creatinine clearance (CrCl) <30 mL/min (GFR can be used in place of creatinine or CrCl).",
            "criterions": [
                {
                    "exact_snippets": "BUN >30",
                    "criterion": "BUN",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine >2",
                    "criterion": "creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "calculated creatinine clearance (CrCl) <30 mL/min",
                    "criterion": "calculated creatinine clearance (CrCl)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "GFR can be used in place of creatinine or CrCl",
                    "criterion": "GFR",
                    "requirements": [
                        {
                            "requirement_type": "substitution",
                            "expected_value": [
                                "creatinine",
                                "CrCl"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Absolute granulocyte count < 1000; platelets <50,000.",
            "criterions": [
                {
                    "exact_snippets": "Absolute granulocyte count < 1000",
                    "criterion": "absolute granulocyte count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1000,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelets <50,000",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 50000,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Bilirubin >2.0; alkaline phosphatase >4x upper limit of normal (ULN); ALT/AST >2x ULN. For patients with hepatic metastases, ALT/AST >5x ULN is exclusionary.",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin >2.0",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.0,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alkaline phosphatase >4x upper limit of normal (ULN)",
                    "criterion": "alkaline phosphatase level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT/AST >2x ULN",
                    "criterion": "ALT/AST level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "For patients with hepatic metastases, ALT/AST >5x ULN is exclusionary",
                    "criterion": "ALT/AST level in patients with hepatic metastases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Proteinuria >1+ on urinalysis or >1 gm/24hr.",
            "criterions": [
                {
                    "exact_snippets": "Proteinuria >1+ on urinalysis",
                    "criterion": "proteinuria",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "+"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Proteinuria ... >1 gm/24hr",
                    "criterion": "proteinuria",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "gm/24hr"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. New York Heart Association stage 3 or 4 cardiac disease.",
            "criterions": [
                {
                    "exact_snippets": "New York Heart Association stage 3 or 4 cardiac disease",
                    "criterion": "New York Heart Association cardiac disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "3",
                                "4"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. A pleural or pericardial effusion of moderate severity or worse.",
            "criterions": [
                {
                    "exact_snippets": "pleural or pericardial effusion of moderate severity or worse",
                    "criterion": "pleural effusion",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "pleural or pericardial effusion of moderate severity or worse",
                    "criterion": "pericardial effusion",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Any woman of childbearing potential (i.e., has had a menstrual cycle within the past year and has not been surgically sterilized), unless she: agrees to take appropriate precautions to avoid becoming pregnant during the study and has a negative serum pregnancy test within 7 days prior to starting treatment.",
            "criterions": [
                {
                    "exact_snippets": "Any woman of childbearing potential (i.e., has had a menstrual cycle within the past year and has not been surgically sterilized)",
                    "criterion": "woman of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "menstrual cycle",
                            "expected_value": "within the past year"
                        },
                        {
                            "requirement_type": "surgical sterilization",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "agrees to take appropriate precautions to avoid becoming pregnant during the study",
                    "criterion": "precautions to avoid becoming pregnant",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has a negative serum pregnancy test within 7 days prior to starting treatment",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days prior to starting treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Men who are fertile/reproductively competent, should take appropriate precautions to avoid fathering a child for the duration of the study.",
            "criterions": [
                {
                    "exact_snippets": "Men who are fertile/reproductively competent",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile/reproductively competent"
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Women who are pregnant or nursing.",
            "criterions": [
                {
                    "exact_snippets": "Women who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Women who are ... nursing",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Patients with concurrent second malignancy.",
            "criterions": [
                {
                    "exact_snippets": "Patients with concurrent second malignancy",
                    "criterion": "second malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Persons with previous malignancies requiring treatment within the past 24 months.",
            "criterions": [
                {
                    "exact_snippets": "previous malignancies requiring treatment within the past 24 months",
                    "criterion": "previous malignancies",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 24,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Patients who have clinical or laboratory features indicative of AIDS and are HIV positive (by self-report).",
            "criterions": [
                {
                    "exact_snippets": "clinical or laboratory features indicative of AIDS",
                    "criterion": "AIDS",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HIV positive (by self-report)",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Have a diagnosis of immunodeficiency, or is receiving chronic systemic steroid therapy (doses exceeding 10 mg daily of prednisone equivalent), or any other form of immunosuppressive therapy within 21 days prior to first dose of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "diagnosis of immunodeficiency",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "receiving chronic systemic steroid therapy (doses exceeding 10 mg daily of prednisone equivalent)",
                    "criterion": "chronic systemic steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg daily of prednisone equivalent"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "any other form of immunosuppressive therapy within 21 days prior to first dose of study treatment",
                    "criterion": "immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 21 days prior to first dose of study treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Patients who are on treatment for an autoimmune disease, unless specifically approved by the Investigator and the Sponsor.",
            "criterions": [
                {
                    "exact_snippets": "Patients who are on treatment for an autoimmune disease",
                    "criterion": "treatment for an autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "20. Patients with severe psychiatric (e.g., schizophrenia, bipolar, or borderline personality disorder) or other clinically progressive major medical problems, unless approved by the Investigator and Sponsor.",
            "criterions": [
                {
                    "exact_snippets": "severe psychiatric (e.g., schizophrenia, bipolar, or borderline personality disorder)",
                    "criterion": "psychiatric condition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "other clinically progressive major medical problems",
                    "criterion": "clinically progressive major medical problems",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": "clinically progressive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "21. Patients may not be on a concurrent clinical trial, unless approved by Investigator and Sponsor.",
            "criterions": [
                {
                    "exact_snippets": "Patients may not be on a concurrent clinical trial",
                    "criterion": "concurrent clinical trial participation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unless approved by Investigator and Sponsor",
                    "criterion": "approval for concurrent clinical trial participation",
                    "requirements": [
                        {
                            "requirement_type": "approval",
                            "expected_value": [
                                "Investigator",
                                "Sponsor"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Key",
            "criterions": [
                {
                    "exact_snippets": "Tissue from tumor must be available",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Tissue from tumor ... > 2 cm in diameter.",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        }
    ]
}