{
    "info": {
        "nct_id": "NCT05656573",
        "official_title": "Phase I Study of CART-PSMA Cells in Patients With Advanced Prostate Cancer",
        "inclusion_criteria": "1. All participants must have the ability to understand and the willingness to sign a written informed consent.\n2. Histologic confirmation of prostate cancer.\n3. Tumor expressing PSMA as demonstrated by immunohistochemistry analysis or other methods.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.\n5. Under general air conditions, blood oxygen saturation >90%.\n6. Adequate liver function, specifically alanine aminotransferase (ALT) < 3 times of upper limit of normal (ULN), aspartate transferase (AST)< 3 times of ULN, serum bilirubin and alkaline phosphatase < 2 times of ULN.\n7. Adequate renal function, specifically serum creatinine < 2.0 mg/dl.\n8. Adequate cardiac function, specifically left ventricular ejection fraction (LVEF)≥50%.\n9. Hemoglobin concentration ≥80g/L.\n10. The side effects brought by the latest treatment should be recovered, and the latest chemotherapy should be at least 7 days before; At least three t½ have passed since the latest immunotherapy.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 35 Years\nMust have maximum age of 85 Years",
        "exclusion_criteria": "1. Patients with other malignant tumors or major diseases.\n2. Patients who are already undergoing other clinical drug trials or other gene therapy or cell therapy.\n3. Patients with uncontrolled active infection.\n4. Patients with active hepatitis B or hepatitis C infection.\n5. Patients with human immunodeficiency virus (HIV) infection.\n6. Patients who are being treated with immunosuppressive agents or systemic steroids (other than inhalation therapy).\n7. Patients with various types of serious heart disease or a history of severe cerebrovascular disease.\n8. Patients with congenital immune deficiency diseases or bone marrow deficiency diseases.\n9. Patients with active autoimmune disease, including connective tissue disease, uveitis, inflammatory bowel disease, or multiple sclerosis; or a history of severe (as judged by the physician-investigator) autoimmune disease requiring prolonged immunosuppressive therapy.\n10. Patients with active medical condition that, in the opinion of the physician-investigator, would substantially increase the risk of uncontrollable CRS (cytokine release syndrome) or CAR Neurotoxicity.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. All participants must have the ability to understand and the willingness to sign a written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a written informed consent",
                    "criterion": "willingness to consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Histologic confirmation of prostate cancer.",
            "criterions": [
                {
                    "exact_snippets": "Histologic confirmation of prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Tumor expressing PSMA as demonstrated by immunohistochemistry analysis or other methods.",
            "criterions": [
                {
                    "exact_snippets": "Tumor expressing PSMA",
                    "criterion": "PSMA expression in tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "as demonstrated by immunohistochemistry analysis or other methods",
                    "criterion": "method of PSMA expression demonstration",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "immunohistochemistry analysis",
                                "other methods"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Under general air conditions, blood oxygen saturation >90%.",
            "criterions": [
                {
                    "exact_snippets": "blood oxygen saturation >90%",
                    "criterion": "blood oxygen saturation",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 90,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Adequate liver function, specifically alanine aminotransferase (ALT) < 3 times of upper limit of normal (ULN), aspartate transferase (AST)< 3 times of ULN, serum bilirubin and alkaline phosphatase < 2 times of ULN.",
            "criterions": [
                {
                    "exact_snippets": "alanine aminotransferase (ALT) < 3 times of upper limit of normal (ULN)",
                    "criterion": "alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "times of ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate transferase (AST)< 3 times of ULN",
                    "criterion": "aspartate transferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "times of ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum bilirubin ... < 2 times of ULN",
                    "criterion": "serum bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "times of ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alkaline phosphatase < 2 times of ULN",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "times of ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Adequate renal function, specifically serum creatinine < 2.0 mg/dl.",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "serum creatinine < 2.0 mg/dl",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.0,
                                "unit": "mg/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Adequate cardiac function, specifically left ventricular ejection fraction (LVEF)≥50%.",
            "criterions": [
                {
                    "exact_snippets": "Adequate cardiac function, specifically left ventricular ejection fraction (LVEF)≥50%.",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Hemoglobin concentration ≥80g/L.",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin concentration ≥80g/L",
                    "criterion": "hemoglobin concentration",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 80,
                                "unit": "g/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. The side effects brought by the latest treatment should be recovered, and the latest chemotherapy should be at least 7 days before; At least three t½ have passed since the latest immunotherapy.",
            "criterions": [
                {
                    "exact_snippets": "The side effects brought by the latest treatment should be recovered",
                    "criterion": "side effects from latest treatment",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the latest chemotherapy should be at least 7 days before",
                    "criterion": "latest chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "At least three t½ have passed since the latest immunotherapy",
                    "criterion": "latest immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "t½"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": "Must be MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 35 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 35 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 35,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 85 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 85 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 85,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Patients with other malignant tumors or major diseases.",
            "criterions": [
                {
                    "exact_snippets": "Patients with other malignant tumors",
                    "criterion": "other malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with ... major diseases",
                    "criterion": "major diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients with uncontrolled active infection.",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled active infection",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients with human immunodeficiency virus (HIV) infection.",
            "criterions": [
                {
                    "exact_snippets": "Patients with human immunodeficiency virus (HIV) infection.",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients who are being treated with immunosuppressive agents or systemic steroids (other than inhalation therapy).",
            "criterions": [
                {
                    "exact_snippets": "Patients who are being treated with immunosuppressive agents",
                    "criterion": "treatment with immunosuppressive agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who are being treated with ... systemic steroids (other than inhalation therapy)",
                    "criterion": "treatment with systemic steroids",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "inhalation therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Patients with various types of serious heart disease or a history of severe cerebrovascular disease.",
            "criterions": [
                {
                    "exact_snippets": "serious heart disease",
                    "criterion": "heart disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of severe cerebrovascular disease",
                    "criterion": "cerebrovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patients with congenital immune deficiency diseases or bone marrow deficiency diseases.",
            "criterions": [
                {
                    "exact_snippets": "Patients with congenital immune deficiency diseases",
                    "criterion": "congenital immune deficiency diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "bone marrow deficiency diseases",
                    "criterion": "bone marrow deficiency diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patients with active autoimmune disease, including connective tissue disease, uveitis, inflammatory bowel disease, or multiple sclerosis; or a history of severe (as judged by the physician-investigator) autoimmune disease requiring prolonged immunosuppressive therapy.",
            "criterions": [
                {
                    "exact_snippets": "Patients with active autoimmune disease",
                    "criterion": "active autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including connective tissue disease",
                    "criterion": "connective tissue disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uveitis",
                    "criterion": "uveitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "inflammatory bowel disease",
                    "criterion": "inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "multiple sclerosis",
                    "criterion": "multiple sclerosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of severe (as judged by the physician-investigator) autoimmune disease requiring prolonged immunosuppressive therapy",
                    "criterion": "history of severe autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "prolonged immunosuppressive therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Patients with active medical condition that, in the opinion of the physician-investigator, would substantially increase the risk of uncontrollable CRS (cytokine release syndrome) or CAR Neurotoxicity.",
            "criterions": [
                {
                    "exact_snippets": "active medical condition ... would substantially increase the risk of uncontrollable CRS (cytokine release syndrome)",
                    "criterion": "active medical condition",
                    "requirements": [
                        {
                            "requirement_type": "risk increase",
                            "expected_value": "substantially increase the risk of uncontrollable CRS (cytokine release syndrome)"
                        }
                    ]
                },
                {
                    "exact_snippets": "active medical condition ... would substantially increase the risk of ... CAR Neurotoxicity",
                    "criterion": "active medical condition",
                    "requirements": [
                        {
                            "requirement_type": "risk increase",
                            "expected_value": "substantially increase the risk of CAR Neurotoxicity"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "2. Patients who are already undergoing other clinical drug trials or other gene therapy or cell therapy.",
            "criterions": [
                {
                    "exact_snippets": "Patients who are already undergoing other clinical drug trials",
                    "criterion": "participation in other clinical drug trials",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who are already undergoing other gene therapy",
                    "criterion": "participation in other gene therapy",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who are already undergoing other ... cell therapy",
                    "criterion": "participation in other cell therapy",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients with active hepatitis B or hepatitis C infection.",
            "criterions": [
                {
                    "exact_snippets": "active hepatitis B",
                    "criterion": "hepatitis B infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active hepatitis C",
                    "criterion": "hepatitis C infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}