{
    "info": {
        "nct_id": "NCT06134960",
        "official_title": "A Single-center, Open-label, Single-arm Clinical Study of the Safety and Efficacy of KD-496 CAR-T Therapy in Advanced NKG2DL+/CLDN18.2+ Solid Tumors",
        "inclusion_criteria": "1. Subjects fully understand the study and voluntarily sign informed consent；\n2. Age 18 to 75 years old (including 75 years old), male and female；\n3. Patients diagnosed with advanced solid tumors by histopathology or cytology and failed at least 2 prior lines treatment; preferentially enrolled in gastric cancer, pancreatic cancer, etc. Standard treatment recommendations refer to the latest version of the National Comprehensive Cancer Network (NCCN) guidelines or the Chinese Society of Clinical Oncology (CSCO) guidelines；\n4. Immunohistochemistry confirmed that NKG2DL/CLDN18.2 was positive (the sum of NKG2DL and CLDN18.2 positive scores ≥5 according to the principle of positive comprehensive score 0~12 points).Tissue specimens for IHC testing must be obtained within 1 year prior to registration for screening or, if not available, new tissue samples must be obtained from a recently obtained surgery or diagnostic biopsy；\n5. Subjects must have measurable lesions as defined by the RECIST v1.1 standard;\n6. ECOG physical status score 0 to 1;\n7. Estimated life expectancy ≥ 3 months;\n8. Subjects must have adequate peripheral venous access for peripheral blood mononuclear cell (PBMC) collection;\n9. Subjects must meet the following conditions prior to screening precondition. If any of the laboratory tests are abnormal, they can be reviewed within 1 week. If the following conditions are still not met, the screening fails:\n\n1)Absolute neutrophil count ≥1.5×10^9/L, platelets ≥90×10^9/L, hemoglobin ≥90 g/L (no blood transfusion or erythropoietin within 14 days) 2)Coagulation parameters: INR≤1.5 times upper limit of normal (ULN), APTT≤1.5 ULN; 3)Liver function: total bilirubin ≤1.5 ULN; Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 ULN; 4)Renal function: creatinine ≤1.5 ULN or creatinine clearance ≥60ml/min (Cockcroft and Gault formula); 5)Lung function: SaO2≥92%; 6)Cardiac function: Cardiac ejection fraction (LVEF) ≥50% detected by echocardiography or MUGA 1 month before enrollment; 10.Male and female participants of reproductive age agreed to use an approved contraceptive method (e.g., contraceptive pill, barrier device, IUD) for the duration of the study until at least 12 months after the last dose of infusion and two consecutive PCR tests found no CAR T cells.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Serologically positive for HIV or treponema pallidum, or active hepatitis B (HBV DNA ≥500 IU/mL) or hepatitis C (anti-HCV positive with HCV RNA above the lower limit of assay detection)\n2. Any active infection that can't be controlled\n3. Patients have autoimmune diseases, have undergone organ transplantation or allogeneic hematopoietic stem cell transplantation, and require long-term systemic glucocorticoid (local use allowed) or other immunosuppressive therapy;\n4. History of severe heart disease, including poorly controlled hypertension (SBP >160mmHg and/or DBP >90mmHg), and any of the following conditions that have occurred in the past 6 months: prolonged QT interval syndrome, ECG shows QTc interval >470mSEC, congestive heart failure (New York Heart Association grade ≥ III), cardiac angioplasty and stenting, myocardial infarction, unstable angina, severe arrhythmia, or other heart disease assessed by the investigator as unsuitable for enrollment;\n5. Brain metastases with clinical symptoms, except for patients who are stable and asymptomatic lasting at least 14 days after radiotherapy or surgery;\n6. Other central nervous system disorders assessed by the investigator to affect the trial: such as seizures, cerebral ischemia/bleeding, dementia, cerebellar diseases, or diseases affecting the central nervous system;\n7. Complicated with hematologic malignancies or other primary malignant solid tumors, except for the following cases: 1) patients with cervical cancer or breast cancer in situ with no evidence of disease for more than 3 years after radical treatment; 2) Patients who have successfully received definitive in situ tumor resection without evidence of disease for ≥5 years;\n8. Patients with unstable or active peptic ulcer or gastrointestinal bleeding;\n9. Received chemotherapy, molecular targeted therapy, interventional therapy, or other antitumor therapy within 3 weeks before apheresis;\n10. Patients have received treatment with genetically modified T cells (including CAR-T, TCR-T) or other immune cell therapy previously;\n11. Female subjects who are pregnant or breastfeeding;\n12. Patients with AEs induced by previous anti-tumor treatment that have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) ≤1, except for alopecia;\n13. Received any live vaccine within 2 weeks prior to enrollment;\n14. Patients are allergic to precondition drugs (including not limited to fludarabine, cyclophosphamide), allergic to KD-496 injection ingredients (dimethyl sulfoxide, human blood albumin), or have a history of severe allergies (such as anaphylactic shock);\n15. Other conditions that investigators considered unsuitable for inclusion;",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Subjects fully understand the study and voluntarily sign informed consent；",
            "criterions": [
                {
                    "exact_snippets": "Subjects fully understand the study",
                    "criterion": "understanding of the study",
                    "requirements": [
                        {
                            "requirement_type": "comprehension",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "voluntarily sign informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Age 18 to 75 years old (including 75 years old), male and female；",
            "criterions": [
                {
                    "exact_snippets": "Age 18 to 75 years old (including 75 years old)",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "male and female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients diagnosed with advanced solid tumors by histopathology or cytology and failed at least 2 prior lines treatment; preferentially enrolled in gastric cancer, pancreatic cancer, etc. Standard treatment recommendations refer to the latest version of the National Comprehensive Cancer Network (NCCN) guidelines or the Chinese Society of Clinical Oncology (CSCO) guidelines；",
            "criterions": [
                {
                    "exact_snippets": "Patients diagnosed with advanced solid tumors",
                    "criterion": "advanced solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "failed at least 2 prior lines treatment",
                    "criterion": "prior lines of treatment",
                    "requirements": [
                        {
                            "requirement_type": "minimum number",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "lines"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "preferentially enrolled in gastric cancer, pancreatic cancer, etc.",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "preference",
                            "expected_value": [
                                "gastric cancer",
                                "pancreatic cancer"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Immunohistochemistry confirmed that NKG2DL/CLDN18.2 was positive (the sum of NKG2DL and CLDN18.2 positive scores ≥5 according to the principle of positive comprehensive score 0~12 points).Tissue specimens for IHC testing must be obtained within 1 year prior to registration for screening or, if not available, new tissue samples must be obtained from a recently obtained surgery or diagnostic biopsy；",
            "criterions": [
                {
                    "exact_snippets": "Immunohistochemistry confirmed that NKG2DL/CLDN18.2 was positive",
                    "criterion": "NKG2DL/CLDN18.2 positivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the sum of NKG2DL and CLDN18.2 positive scores ≥5 according to the principle of positive comprehensive score 0~12 points",
                    "criterion": "NKG2DL and CLDN18.2 positive scores",
                    "requirements": [
                        {
                            "requirement_type": "sum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "points"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Tissue specimens for IHC testing must be obtained within 1 year prior to registration for screening",
                    "criterion": "tissue specimen collection time",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 1 year prior to registration"
                        }
                    ]
                },
                {
                    "exact_snippets": "if not available, new tissue samples must be obtained from a recently obtained surgery or diagnostic biopsy",
                    "criterion": "new tissue sample collection",
                    "requirements": [
                        {
                            "requirement_type": "source",
                            "expected_value": [
                                "recent surgery",
                                "diagnostic biopsy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Subjects must have measurable lesions as defined by the RECIST v1.1 standard;",
            "criterions": [
                {
                    "exact_snippets": "measurable lesions as defined by the RECIST v1.1 standard",
                    "criterion": "lesions",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": "RECIST v1.1 standard"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. ECOG physical status score 0 to 1;",
            "criterions": [
                {
                    "exact_snippets": "ECOG physical status score 0 to 1",
                    "criterion": "ECOG physical status score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Estimated life expectancy ≥ 3 months;",
            "criterions": [
                {
                    "exact_snippets": "Estimated life expectancy ≥ 3 months;",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Subjects must have adequate peripheral venous access for peripheral blood mononuclear cell (PBMC) collection;",
            "criterions": [
                {
                    "exact_snippets": "adequate peripheral venous access",
                    "criterion": "peripheral venous access",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Subjects must meet the following conditions prior to screening precondition. If any of the laboratory tests are abnormal, they can be reviewed within 1 week. If the following conditions are still not met, the screening fails:",
            "criterions": [
                {
                    "exact_snippets": "laboratory tests are abnormal",
                    "criterion": "laboratory tests",
                    "requirements": [
                        {
                            "requirement_type": "normality",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1)Absolute neutrophil count ≥1.5×10^9/L, platelets ≥90×10^9/L, hemoglobin ≥90 g/L (no blood transfusion or erythropoietin within 14 days) 2)Coagulation parameters: INR≤1.5 times upper limit of normal (ULN), APTT≤1.5 ULN; 3)Liver function: total bilirubin ≤1.5 ULN; Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 ULN; 4)Renal function: creatinine ≤1.5 ULN or creatinine clearance ≥60ml/min (Cockcroft and Gault formula); 5)Lung function: SaO2≥92%; 6)Cardiac function: Cardiac ejection fraction (LVEF) ≥50% detected by echocardiography or MUGA 1 month before enrollment; 10.Male and female participants of reproductive age agreed to use an approved contraceptive method (e.g., contraceptive pill, barrier device, IUD) for the duration of the study until at least 12 months after the last dose of infusion and two consecutive PCR tests found no CAR T cells.",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count ≥1.5×10^9/L",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelets ≥90×10^9/L",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoglobin ≥90 g/L (no blood transfusion or erythropoietin within 14 days)",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        },
                        {
                            "requirement_type": "blood transfusion or erythropoietin",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Coagulation parameters: INR≤1.5 times upper limit of normal (ULN)",
                    "criterion": "INR",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "APTT≤1.5 ULN",
                    "criterion": "APTT",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Liver function: total bilirubin ≤1.5 ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 ULN",
                    "criterion": "Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Renal function: creatinine ≤1.5 ULN",
                    "criterion": "creatinine",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance ≥60ml/min (Cockcroft and Gault formula)",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "ml/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Lung function: SaO2≥92%",
                    "criterion": "SaO2",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 92,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Cardiac function: Cardiac ejection fraction (LVEF) ≥50% detected by echocardiography or MUGA 1 month before enrollment",
                    "criterion": "Cardiac ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Male and female participants of reproductive age agreed to use an approved contraceptive method (e.g., contraceptive pill, barrier device, IUD) for the duration of the study until at least 12 months after the last dose of infusion and two consecutive PCR tests found no CAR T cells",
                    "criterion": "use of an approved contraceptive method",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "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 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Serologically positive for HIV or treponema pallidum, or active hepatitis B (HBV DNA ≥500 IU/mL) or hepatitis C (anti-HCV positive with HCV RNA above the lower limit of assay detection)",
            "criterions": [
                {
                    "exact_snippets": "Serologically positive for HIV",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "serological status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Serologically positive for ... treponema pallidum",
                    "criterion": "treponema pallidum status",
                    "requirements": [
                        {
                            "requirement_type": "serological status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "active hepatitis B (HBV DNA ≥500 IU/mL)",
                    "criterion": "hepatitis B status",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "HBV DNA level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 500,
                                "unit": "IU/mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis C (anti-HCV positive with HCV RNA above the lower limit of assay detection)",
                    "criterion": "hepatitis C status",
                    "requirements": [
                        {
                            "requirement_type": "anti-HCV status",
                            "expected_value": "positive"
                        },
                        {
                            "requirement_type": "HCV RNA level",
                            "expected_value": "above the lower limit of assay detection"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Any active infection that can't be controlled",
            "criterions": [
                {
                    "exact_snippets": "Any active infection",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients have autoimmune diseases, have undergone organ transplantation or allogeneic hematopoietic stem cell transplantation, and require long-term systemic glucocorticoid (local use allowed) or other immunosuppressive therapy;",
            "criterions": [
                {
                    "exact_snippets": "Patients have autoimmune diseases",
                    "criterion": "autoimmune diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "have undergone organ transplantation",
                    "criterion": "organ transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "allogeneic hematopoietic stem cell transplantation",
                    "criterion": "allogeneic hematopoietic stem cell transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "require long-term systemic glucocorticoid ... or other immunosuppressive therapy",
                    "criterion": "long-term systemic glucocorticoid or other immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. History of severe heart disease, including poorly controlled hypertension (SBP >160mmHg and/or DBP >90mmHg), and any of the following conditions that have occurred in the past 6 months: prolonged QT interval syndrome, ECG shows QTc interval >470mSEC, congestive heart failure (New York Heart Association grade ≥ III), cardiac angioplasty and stenting, myocardial infarction, unstable angina, severe arrhythmia, or other heart disease assessed by the investigator as unsuitable for enrollment;",
            "criterions": [
                {
                    "exact_snippets": "History of severe heart disease",
                    "criterion": "severe heart disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "poorly controlled hypertension (SBP >160mmHg and/or DBP >90mmHg)",
                    "criterion": "poorly controlled hypertension",
                    "requirements": [
                        {
                            "requirement_type": "systolic blood pressure",
                            "expected_value": {
                                "operator": ">",
                                "value": 160,
                                "unit": "mmHg"
                            }
                        },
                        {
                            "requirement_type": "diastolic blood pressure",
                            "expected_value": {
                                "operator": ">",
                                "value": 90,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "prolonged QT interval syndrome",
                    "criterion": "prolonged QT interval syndrome",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ECG shows QTc interval >470mSEC",
                    "criterion": "QTc interval",
                    "requirements": [
                        {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "operator": ">",
                                "value": 470,
                                "unit": "mSEC"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure (New York Heart Association grade ≥ III)",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "New York Heart Association grade",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac angioplasty and stenting",
                    "criterion": "cardiac angioplasty and stenting",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "severe arrhythmia",
                    "criterion": "severe arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other heart disease assessed by the investigator as unsuitable for enrollment",
                    "criterion": "other heart disease",
                    "requirements": [
                        {
                            "requirement_type": "suitability for enrollment",
                            "expected_value": "assessed by the investigator as unsuitable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Brain metastases with clinical symptoms, except for patients who are stable and asymptomatic lasting at least 14 days after radiotherapy or surgery;",
            "criterions": [
                {
                    "exact_snippets": "Brain metastases with clinical symptoms",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "clinical symptoms"
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who are stable and asymptomatic lasting at least 14 days after radiotherapy or surgery",
                    "criterion": "stability and symptoms post-treatment",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "asymptomatic"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "radiotherapy",
                                "surgery"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Other central nervous system disorders assessed by the investigator to affect the trial: such as seizures, cerebral ischemia/bleeding, dementia, cerebellar diseases, or diseases affecting the central nervous system;",
            "criterions": [
                {
                    "exact_snippets": "Other central nervous system disorders ... such as seizures",
                    "criterion": "seizures",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Other central nervous system disorders ... such as ... cerebral ischemia/bleeding",
                    "criterion": "cerebral ischemia/bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Other central nervous system disorders ... such as ... dementia",
                    "criterion": "dementia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Other central nervous system disorders ... such as ... cerebellar diseases",
                    "criterion": "cerebellar diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Other central nervous system disorders ... such as ... diseases affecting the central nervous system",
                    "criterion": "diseases affecting the central nervous system",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Complicated with hematologic malignancies or other primary malignant solid tumors, except for the following cases: 1) patients with cervical cancer or breast cancer in situ with no evidence of disease for more than 3 years after radical treatment; 2) Patients who have successfully received definitive in situ tumor resection without evidence of disease for ≥5 years;",
            "criterions": [
                {
                    "exact_snippets": "Complicated with hematologic malignancies",
                    "criterion": "hematologic malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other primary malignant solid tumors",
                    "criterion": "primary malignant solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with cervical cancer or breast cancer in situ with no evidence of disease for more than 3 years after radical treatment",
                    "criterion": "cervical cancer or breast cancer in situ",
                    "requirements": [
                        {
                            "requirement_type": "evidence of disease",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time since radical treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who have successfully received definitive in situ tumor resection without evidence of disease for ≥5 years",
                    "criterion": "definitive in situ tumor resection",
                    "requirements": [
                        {
                            "requirement_type": "evidence of disease",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time since resection",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patients with unstable or active peptic ulcer or gastrointestinal bleeding;",
            "criterions": [
                {
                    "exact_snippets": "unstable or active peptic ulcer",
                    "criterion": "peptic ulcer",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "gastrointestinal bleeding",
                    "criterion": "gastrointestinal bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Received chemotherapy, molecular targeted therapy, interventional therapy, or other antitumor therapy within 3 weeks before apheresis;",
            "criterions": [
                {
                    "exact_snippets": "Received chemotherapy ... within 3 weeks before apheresis",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Received ... molecular targeted therapy ... within 3 weeks before apheresis",
                    "criterion": "molecular targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Received ... interventional therapy ... within 3 weeks before apheresis",
                    "criterion": "interventional therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Received ... other antitumor therapy within 3 weeks before apheresis",
                    "criterion": "other antitumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Patients have received treatment with genetically modified T cells (including CAR-T, TCR-T) or other immune cell therapy previously;",
            "criterions": [
                {
                    "exact_snippets": "received treatment with genetically modified T cells (including CAR-T, TCR-T) or other immune cell therapy previously",
                    "criterion": "previous treatment with genetically modified T cells or other immune cell therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Female subjects who are pregnant or breastfeeding;",
            "criterions": [
                {
                    "exact_snippets": "Female subjects who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Female subjects who are ... breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Patients with AEs induced by previous anti-tumor treatment that have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) ≤1, except for alopecia;",
            "criterions": [
                {
                    "exact_snippets": "AEs induced by previous anti-tumor treatment that have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) ≤1",
                    "criterion": "adverse events (AEs)",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "CTCAE"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for alopecia",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Received any live vaccine within 2 weeks prior to enrollment;",
            "criterions": [
                {
                    "exact_snippets": "Received any live vaccine within 2 weeks prior to enrollment",
                    "criterion": "live vaccine",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Patients are allergic to precondition drugs (including not limited to fludarabine, cyclophosphamide), allergic to KD-496 injection ingredients (dimethyl sulfoxide, human blood albumin), or have a history of severe allergies (such as anaphylactic shock);",
            "criterions": [
                {
                    "exact_snippets": "allergic to precondition drugs (including not limited to fludarabine, cyclophosphamide)",
                    "criterion": "allergy to precondition drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "allergic to KD-496 injection ingredients (dimethyl sulfoxide, human blood albumin)",
                    "criterion": "allergy to KD-496 injection ingredients",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of severe allergies (such as anaphylactic shock)",
                    "criterion": "history of severe allergies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Other conditions that investigators considered unsuitable for inclusion;",
            "criterions": [
                {
                    "exact_snippets": "Other conditions that investigators considered unsuitable for inclusion",
                    "criterion": "other conditions",
                    "requirements": [
                        {
                            "requirement_type": "suitability for inclusion",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}