{
    "info": {
        "nct_id": "NCT05895994",
        "official_title": "A Study on the Efficacy, Safety and Cellular Pharmacokinetics of RD13-02 Cell Injection in Patients With Relapsed or Refractory CD7-positive Hematological Malignancies",
        "inclusion_criteria": "1. Age 3-70\n2. Diagnosis of r/r T-ALL/LBL/AML.\n3. CD7 positive expression\n4. Bone marrow lymphoblasts ≥5% by morphologic evaluation at screening\n5. Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min, Serum alanine aminotransferase(ALT)/aspartate aminotransferase(AST) < 3×upper limit of normal, Total bilirubin < 1.5×upper limit of normal or ≤1.5mg/dl\n6. Left ventricular ejection fraction ≥ 50% .\n7. Baseline oxygen saturation ≥ 92% on room air.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n9. The estimated survival time is more than 3 months.\n10. Subjects or their legal guardians volunteer to participate in the study and sign the informed consent.\nHealthy volunteers allowed\nMust have minimum age of 3 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "1. Subjects with concomitant genetic syndromes associated with bone marrow failure states.\n2. Isolated extramedullary lesions\n3. Subjects with some cardiac conditions will be excluded.\n4. With uncontrolled active central nervous system leukemia (CNSL), cerebrospinal fluid grade Central Nervous System3(CNS3).\n5. History of traumatic brain injury, consciousness disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic disease, which might compromise the ability of the subject to compliance with the obligations under the protocol.\n6. History of malignancy other than non-melanoma skin cancer or carcinoma.\n7. Primary immune deficiency.\n8. Presence of uncontrolled infections.\n9. Subjects with some anticancer therapy before CAR-T infusion will be excluded.\n10. Active uncontrolled acute infections.\n11. Known history of infection with human immunodeficiency virus (HIV); active or latent hepatitis B, hepatitis C and syphilis.\n12. Subjects who are receiving systemic steroid therapy prior to screening.\n\n14.Having received live/attenuated vaccine within 4 weeks prior to screening. 15.History of allergy to any component of the cell therapy product. 16.Pregnant or breastfeeding women 17.Any other issue which, in the opinion of the investigator, would make the subjects ineligible for the study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age 3-70",
            "criterions": [
                {
                    "exact_snippets": "Age 3-70",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Diagnosis of r/r T-ALL/LBL/AML.",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of r/r T-ALL",
                    "criterion": "T-ALL",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "r/r"
                        }
                    ]
                },
                {
                    "exact_snippets": "Diagnosis of ... LBL",
                    "criterion": "LBL",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "r/r"
                        }
                    ]
                },
                {
                    "exact_snippets": "Diagnosis of ... AML",
                    "criterion": "AML",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "r/r"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. CD7 positive expression",
            "criterions": [
                {
                    "exact_snippets": "CD7 positive expression",
                    "criterion": "CD7 expression",
                    "requirements": [
                        {
                            "requirement_type": "expression",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Bone marrow lymphoblasts ≥5% by morphologic evaluation at screening",
            "criterions": [
                {
                    "exact_snippets": "Bone marrow lymphoblasts ≥5% by morphologic evaluation at screening",
                    "criterion": "bone marrow lymphoblasts",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "evaluation method",
                            "expected_value": "morphologic evaluation"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "at screening"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min, Serum alanine aminotransferase(ALT)/aspartate aminotransferase(AST) < 3×upper limit of normal, Total bilirubin < 1.5×upper limit of normal or ≤1.5mg/dl",
            "criterions": [
                {
                    "exact_snippets": "Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "estimation method",
                            "expected_value": "Cockcroft Gault"
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Serum alanine aminotransferase(ALT)/aspartate aminotransferase(AST) < 3×upper limit of normal",
                    "criterion": "serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "×upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Total bilirubin < 1.5×upper limit of normal or ≤1.5mg/dl",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                ">",
                                "1.5×upper limit of normal",
                                "≤1.5mg/dl"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Left ventricular ejection fraction ≥ 50% .",
            "criterions": [
                {
                    "exact_snippets": "Left ventricular ejection fraction ≥ 50%",
                    "criterion": "left ventricular ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Baseline oxygen saturation ≥ 92% on room air.",
            "criterions": [
                {
                    "exact_snippets": "Baseline oxygen saturation ≥ 92%",
                    "criterion": "oxygen saturation",
                    "requirements": [
                        {
                            "requirement_type": "baseline level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 92,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "on room air",
                    "criterion": "oxygen saturation",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "room air"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 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": "9. The estimated survival time is more than 3 months.",
            "criterions": [
                {
                    "exact_snippets": "The estimated survival time is more than 3 months.",
                    "criterion": "estimated survival time",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Subjects or their legal guardians volunteer to participate in the study and sign the informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Subjects or their legal guardians volunteer to participate in the study",
                    "criterion": "voluntary participation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sign the informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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 3 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 3 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Subjects with concomitant genetic syndromes associated with bone marrow failure states.",
            "criterions": [
                {
                    "exact_snippets": "concomitant genetic syndromes associated with bone marrow failure states",
                    "criterion": "genetic syndromes",
                    "requirements": [
                        {
                            "requirement_type": "association",
                            "expected_value": "bone marrow failure states"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Isolated extramedullary lesions",
            "criterions": [
                {
                    "exact_snippets": "Isolated extramedullary lesions",
                    "criterion": "extramedullary lesions",
                    "requirements": [
                        {
                            "requirement_type": "isolation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Subjects with some cardiac conditions will be excluded.",
            "criterions": [
                {
                    "exact_snippets": "cardiac conditions",
                    "criterion": "cardiac conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. With uncontrolled active central nervous system leukemia (CNSL), cerebrospinal fluid grade Central Nervous System3(CNS3).",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled active central nervous system leukemia (CNSL)",
                    "criterion": "central nervous system leukemia (CNSL)",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "activity status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "cerebrospinal fluid grade Central Nervous System3(CNS3)",
                    "criterion": "cerebrospinal fluid grade",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": "Central Nervous System3 (CNS3)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. History of traumatic brain injury, consciousness disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic disease, which might compromise the ability of the subject to compliance with the obligations under the protocol.",
            "criterions": [
                {
                    "exact_snippets": "History of traumatic brain injury",
                    "criterion": "traumatic brain injury",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... consciousness disturbance",
                    "criterion": "consciousness disturbance",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... epilepsy",
                    "criterion": "epilepsy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... cerebrovascular ischemia",
                    "criterion": "cerebrovascular ischemia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... cerebrovascular hemorrhagic disease",
                    "criterion": "cerebrovascular hemorrhagic disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. History of malignancy other than non-melanoma skin cancer or carcinoma.",
            "criterions": [
                {
                    "exact_snippets": "History of malignancy other than non-melanoma skin cancer or carcinoma.",
                    "criterion": "history of malignancy",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "non-melanoma skin cancer",
                                "carcinoma"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Primary immune deficiency.",
            "criterions": [
                {
                    "exact_snippets": "Primary immune deficiency",
                    "criterion": "primary immune deficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Presence of uncontrolled infections.",
            "criterions": [
                {
                    "exact_snippets": "Presence of uncontrolled infections",
                    "criterion": "uncontrolled infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Subjects with some anticancer therapy before CAR-T infusion will be excluded.",
            "criterions": [
                {
                    "exact_snippets": "anticancer therapy before CAR-T infusion",
                    "criterion": "prior anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Active uncontrolled acute infections.",
            "criterions": [
                {
                    "exact_snippets": "Active uncontrolled acute infections",
                    "criterion": "acute infections",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "activity status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Known history of infection with human immunodeficiency virus (HIV); active or latent hepatitis B, hepatitis C and syphilis.",
            "criterions": [
                {
                    "exact_snippets": "Known history of infection with human immunodeficiency virus (HIV)",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active or latent hepatitis B",
                    "criterion": "hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "latent"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "active or latent ... hepatitis C",
                    "criterion": "hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "latent"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "active or latent ... syphilis",
                    "criterion": "syphilis",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "latent"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Subjects who are receiving systemic steroid therapy prior to screening.",
            "criterions": [
                {
                    "exact_snippets": "Subjects who are receiving systemic steroid therapy",
                    "criterion": "systemic steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14.Having received live/attenuated vaccine within 4 weeks prior to screening. 15.History of allergy to any component of the cell therapy product. 16.Pregnant or breastfeeding women 17.Any other issue which, in the opinion of the investigator, would make the subjects ineligible for the study.",
            "criterions": [
                {
                    "exact_snippets": "Having received live/attenuated vaccine within 4 weeks prior to screening.",
                    "criterion": "live/attenuated vaccine",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "History of allergy to any component of the cell therapy product.",
                    "criterion": "allergy to cell therapy product",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Pregnant or breastfeeding women",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Pregnant or breastfeeding women",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Any other issue which, in the opinion of the investigator, would make the subjects ineligible for the study.",
                    "criterion": "investigator's opinion on eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": "ineligible"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}