{
    "info": {
        "nct_id": "NCT05736731",
        "official_title": "A Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B530, an Autologous Logic-gated Tmod™ Chimeric Antigen Receptor T Cell (CAR T), in Heterozygous HLA-A*02 Adult Subjects with Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express CEA and Have Lost HLA-A*02 Expression",
        "inclusion_criteria": "1. Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A*02:01 by NGS (whenever possible from the primary site), successful apheresis and PBMC processing, and with sufficient stored cells available for Tmod CAR T-cell therapy\n2. Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, PANC, or other solid tumors associated with CEA expression. Measurable disease is required with lesions of >1.0 cm by computed tomography (CT). (Soluble CEA is not acceptable as the sole measure of disease).\n3. Received previous required therapy for the appropriate solid tumor disease as described in the protocol\n4. Has adequate organ function as described in the protocol\n5. ECOG performance status of 0 to 1\n6. Life expectancy of ≥3 months\n7. Willing to comply with study schedule of assessments including long term safety follow up\n\nKey\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative\n2. Prior allogeneic stem cell transplant\n3. Prior solid organ transplant\n4. Cancer therapy within 3 weeks or 3 half lives of A2B530 infusion\n5. Radiotherapy within 28 days of A2B530 infusion\n6. Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months\n7. Any new symptomatic pulmonary embolism (PE) or a deep vein thrombosis (DVT) within 3 months of enrollment. Therapeutic dosing of anticoagulants is allowed for history of PE or DVT if greater than 3 months from time of enrollment, and adequately treated.\n8. Requires supplemental home oxygen\n9. Females of childbearing potential who are pregnant or breastfeeding\n10. Subjects, both male and female, of childbearing potential who are not willing to practice birth control from the time of consent through 6 months post infusion of A2B530",
        "miscellaneous_criteria": "Key"
    },
    "inclusion_lines": [
        {
            "line": "1. Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A*02:01 by NGS (whenever possible from the primary site), successful apheresis and PBMC processing, and with sufficient stored cells available for Tmod CAR T-cell therapy",
            "criterions": [
                {
                    "exact_snippets": "Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study",
                    "criterion": "enrollment in BASECAMP-1 A2 Biotherapeutics, Inc. study",
                    "requirements": [
                        {
                            "requirement_type": "enrollment status",
                            "expected_value": "appropriately enrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "tissue demonstrating LOH of HLA-A*02:01 by NGS",
                    "criterion": "LOH of HLA-A*02:01",
                    "requirements": [
                        {
                            "requirement_type": "detection method",
                            "expected_value": "NGS"
                        }
                    ]
                },
                {
                    "exact_snippets": "successful apheresis",
                    "criterion": "apheresis",
                    "requirements": [
                        {
                            "requirement_type": "success",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "successful ... PBMC processing",
                    "criterion": "PBMC processing",
                    "requirements": [
                        {
                            "requirement_type": "success",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sufficient stored cells available for Tmod CAR T-cell therapy",
                    "criterion": "stored cells for Tmod CAR T-cell therapy",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": "sufficient"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, PANC, or other solid tumors associated with CEA expression. Measurable disease is required with lesions of >1.0 cm by computed tomography (CT). (Soluble CEA is not acceptable as the sole measure of disease).",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, PANC, or other solid tumors",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "histological confirmation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "recurrence status",
                            "expected_value": "recurrent"
                        },
                        {
                            "requirement_type": "resectability",
                            "expected_value": "unresectable"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        },
                        {
                            "requirement_type": "cancer types",
                            "expected_value": [
                                "CRC",
                                "NSCLC",
                                "PANC",
                                "other solid tumors"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "associated with CEA expression",
                    "criterion": "CEA expression",
                    "requirements": [
                        {
                            "requirement_type": "association",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Measurable disease is required",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "lesions of >1.0 cm by computed tomography (CT)",
                    "criterion": "lesion size",
                    "requirements": [
                        {
                            "requirement_type": "measurement method",
                            "expected_value": "computed tomography (CT)"
                        },
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.0,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Soluble CEA is not acceptable as the sole measure of disease",
                    "criterion": "soluble CEA",
                    "requirements": [
                        {
                            "requirement_type": "acceptability as sole measure",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Received previous required therapy for the appropriate solid tumor disease as described in the protocol",
            "criterions": [
                {
                    "exact_snippets": "Received previous required therapy",
                    "criterion": "previous therapy",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "appropriate solid tumor disease",
                    "criterion": "solid tumor disease",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": "as described in the protocol"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Has adequate organ function as described in the protocol",
            "criterions": [
                {
                    "exact_snippets": "adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "as described in the protocol"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. ECOG performance status of 0 to 1",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 0 to 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Life expectancy of ≥3 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of ≥3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Willing to comply with study schedule of assessments including long term safety follow up",
            "criterions": [
                {
                    "exact_snippets": "Willing to comply with study schedule of assessments",
                    "criterion": "compliance with study schedule",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including long term safety follow up",
                    "criterion": "long term safety follow up",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Key",
            "criterions": [
                {
                    "exact_snippets": "Key",
                    "criterion": "key",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "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. Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative",
            "criterions": [
                {
                    "exact_snippets": "disease that is suitable for local therapy",
                    "criterion": "disease suitability for local therapy",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "able to receive standard of care therapy that is therapeutic and not palliative",
                    "criterion": "ability to receive standard of care therapy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "therapeutic"
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": "not palliative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Prior allogeneic stem cell transplant",
            "criterions": [
                {
                    "exact_snippets": "Prior allogeneic stem cell transplant",
                    "criterion": "allogeneic stem cell transplant",
                    "requirements": [
                        {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Prior solid organ transplant",
            "criterions": [
                {
                    "exact_snippets": "Prior solid organ transplant",
                    "criterion": "solid organ transplant",
                    "requirements": [
                        {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Cancer therapy within 3 weeks or 3 half lives of A2B530 infusion",
            "criterions": [
                {
                    "exact_snippets": "Cancer therapy within 3 weeks or 3 half lives of A2B530 infusion",
                    "criterion": "cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "half lives"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Radiotherapy within 28 days of A2B530 infusion",
            "criterions": [
                {
                    "exact_snippets": "Radiotherapy within 28 days of A2B530 infusion",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months",
            "criterions": [
                {
                    "exact_snippets": "Unstable angina ... within the last 6 months",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "arrhythmia ... within the last 6 months",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction ... within the last 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "any other significant cardiac disease within the last 6 months",
                    "criterion": "significant cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Any new symptomatic pulmonary embolism (PE) or a deep vein thrombosis (DVT) within 3 months of enrollment. Therapeutic dosing of anticoagulants is allowed for history of PE or DVT if greater than 3 months from time of enrollment, and adequately treated.",
            "criterions": [
                {
                    "exact_snippets": "Any new symptomatic pulmonary embolism (PE)",
                    "criterion": "new symptomatic pulmonary embolism (PE)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "a deep vein thrombosis (DVT) within 3 months of enrollment",
                    "criterion": "deep vein thrombosis (DVT)",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Therapeutic dosing of anticoagulants is allowed for history of PE or DVT if greater than 3 months from time of enrollment, and adequately treated",
                    "criterion": "therapeutic dosing of anticoagulants for history of PE or DVT",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        },
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Requires supplemental home oxygen",
            "criterions": [
                {
                    "exact_snippets": "Requires supplemental home oxygen",
                    "criterion": "supplemental home oxygen",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Females of childbearing potential who are pregnant or breastfeeding",
            "criterions": [
                {
                    "exact_snippets": "Females of childbearing potential",
                    "criterion": "females of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Subjects, both male and female, of childbearing potential who are not willing to practice birth control from the time of consent through 6 months post infusion of A2B530",
            "criterions": [
                {
                    "exact_snippets": "Subjects, both male and female, of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not willing to practice birth control from the time of consent through 6 months post infusion of A2B530",
                    "criterion": "willingness to practice birth control",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [
        {
            "line": "Key",
            "criterions": [
                {
                    "exact_snippets": "Key",
                    "criterion": "key",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}