{
    "info": {
        "nct_id": "NCT06475131",
        "official_title": "A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics and Preliminary Efficacy of BL-B16D1 in Patients With Locally Advanced or Metastatic Solid Tumors",
        "inclusion_criteria": "1. Sign the informed consent form voluntarily and follow the protocol requirements;\n2. Gender is not limited;\n3. Age: ≥18 years old and ≤75 years old (phase Ia); ≥18 years old (phase Ib);\n4. Expected survival time ≥3 months;\n5. locally advanced or metastatic solid tumors confirmed by histopathology and/or cytology that failed standard treatment or could not obtain standard treatment;\n6. Consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 3 years;\n7. At least one measurable lesion meeting the RECIST v1.1 definition was required;\n8. ECOG 0 or 1;\n9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;\n10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;\n11. The organ function level must meet the requirements if the patient has not received blood transfusion or hematopoietic stimulating factor therapy within 14 days before screening;\n12. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5ULN;\n13. Urinary protein ≤2+ or ≤1000mg/24h;\n14. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and the patient must not be lactating; All enrolled patients (male or female) should use adequate contraception throughout the treatment cycle and for 6 months after completion of treatment.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Chemotherapy, biological therapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral drugs such as fluorouracil;\n2. History of severe heart disease;\n3. Long QT, complete left bundle branch block, III degree atrioventricular block;\n4. Active autoimmune and inflammatory diseases;\n5. Other malignancies diagnosed within 5 years before the first dose;\n6. Hypertension poorly controlled by two antihypertensive drugs;\n7. Patients with poor glycemic control;\n8. Present with grade ≥2 radiation pneumonitis according to the RTOG/EORTC definition; Previous history of ILD or current ILD, or suspicion of such disease during screening;\n9. Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;\n10. Active central nervous system metastasis;\n11. Patients with a history of allergy to recombinant humanized or human-mouse chimeric antibodies or to any of the excipients of BL-B16D1;\n12. Received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);\n13. The cumulative dose of anthracyclines > 360 mg/m2 in previous (new) adjuvant therapy;\n14. Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;\n15. Severe infection occurred within 4 weeks before the first dose; Signs of pulmonary infection or active pulmonary inflammation within 2 weeks before the first dose;\n16. Patients with massive or symptomatic effusions or poorly controlled effusions;\n17. Had participated in another clinical trial within 4 weeks before the first dose;\n18. Had the following ocular diseases: a. active infection or corneal ulcer; b. monocular vision; c. a history of corneal transplantation; d. Contact lens dependence; e. Uncontrolled glaucoma; f. Uncontrolled or progressive retinopathy, wet macular degeneration, etc.;\n19. Other circumstances that the investigator deemed inappropriate for participation in the trial.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Sign the informed consent form voluntarily and follow the protocol requirements;",
            "criterions": [
                {
                    "exact_snippets": "Sign the informed consent form voluntarily",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "follow the protocol requirements",
                    "criterion": "protocol adherence",
                    "requirements": [
                        {
                            "requirement_type": "adherence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Gender is not limited;",
            "criterions": [
                {
                    "exact_snippets": "Gender is not limited",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "restriction",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Age: ≥18 years old and ≤75 years old (phase Ia); ≥18 years old (phase Ib);",
            "criterions": [
                {
                    "exact_snippets": "Age: ≥18 years old and ≤75 years old (phase Ia)",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Age: ... ≥18 years old (phase Ib)",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Expected survival time ≥3 months;",
            "criterions": [
                {
                    "exact_snippets": "Expected survival time ≥3 months",
                    "criterion": "expected survival time",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. locally advanced or metastatic solid tumors confirmed by histopathology and/or cytology that failed standard treatment or could not obtain standard treatment;",
            "criterions": [
                {
                    "exact_snippets": "locally advanced or metastatic solid tumors",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed by histopathology and/or cytology",
                    "criterion": "tumor confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histopathology",
                                "cytology"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "failed standard treatment",
                    "criterion": "treatment history",
                    "requirements": [
                        {
                            "requirement_type": "treatment outcome",
                            "expected_value": "failed"
                        }
                    ]
                },
                {
                    "exact_snippets": "could not obtain standard treatment",
                    "criterion": "treatment availability",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 3 years;",
            "criterions": [
                {
                    "exact_snippets": "Consent to provide archival tumor tissue samples or fresh tissue samples",
                    "criterion": "tumor tissue samples",
                    "requirements": [
                        {
                            "requirement_type": "consent",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "fresh tissue samples from primary or metastatic lesions within 3 years",
                    "criterion": "fresh tissue samples",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. At least one measurable lesion meeting the RECIST v1.1 definition was required;",
            "criterions": [
                {
                    "exact_snippets": "At least one measurable lesion meeting the RECIST v1.1 definition",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "definition",
                            "expected_value": "RECIST v1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. ECOG 0 or 1;",
            "criterions": [
                {
                    "exact_snippets": "ECOG 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;",
            "criterions": [
                {
                    "exact_snippets": "The toxicity of previous antineoplastic therapy has returned to ≤ grade 1",
                    "criterion": "toxicity of previous antineoplastic therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;",
            "criterions": [
                {
                    "exact_snippets": "No severe cardiac dysfunction",
                    "criterion": "cardiac dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "left ventricular ejection fraction ≥50%",
                    "criterion": "left ventricular ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. The organ function level must meet the requirements if the patient has not received blood transfusion or hematopoietic stimulating factor therapy within 14 days before screening;",
            "criterions": [
                {
                    "exact_snippets": "organ function level must meet the requirements",
                    "criterion": "organ function level",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "must meet the requirements"
                        }
                    ]
                },
                {
                    "exact_snippets": "if the patient has not received blood transfusion",
                    "criterion": "blood transfusion",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hematopoietic stimulating factor therapy",
                    "criterion": "hematopoietic stimulating factor therapy",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "within 14 days before screening",
                    "criterion": "time since last treatment",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5ULN;",
            "criterions": [
                {
                    "exact_snippets": "Coagulation function: international normalized ratio ≤1.5",
                    "criterion": "international normalized ratio",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Coagulation function: ... activated partial thromboplastin time ≤1.5ULN",
                    "criterion": "activated partial thromboplastin time",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Urinary protein ≤2+ or ≤1000mg/24h;",
            "criterions": [
                {
                    "exact_snippets": "Urinary protein ≤2+",
                    "criterion": "urinary protein level",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "+"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Urinary protein ... ≤1000mg/24h",
                    "criterion": "urinary protein excretion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1000,
                                "unit": "mg/24h"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and the patient must not be lactating; All enrolled patients (male or female) should use adequate contraception throughout the treatment cycle and for 6 months after completion of treatment.",
            "criterions": [
                {
                    "exact_snippets": "premenopausal women with childbearing potential",
                    "criterion": "premenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "a pregnancy test must be performed within 7 days before starting treatment",
                    "criterion": "pregnancy test timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum pregnancy must be negative",
                    "criterion": "serum pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "the patient must not be lactating",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "All enrolled patients (male or female) should use adequate contraception throughout the treatment cycle and for 6 months after completion of treatment",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "throughout the treatment cycle and for 6 months after completion of treatment"
                        }
                    ]
                }
            ]
        },
        {
            "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. Chemotherapy, biological therapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral drugs such as fluorouracil;",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy, biological therapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose",
                    "criterion": "use of chemotherapy, biological therapy, and other anti-tumor therapies",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "half-lives"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Mitomycin and nitrosoureas were administered within 6 weeks before the first dose",
                    "criterion": "use of Mitomycin and nitrosoureas",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Oral drugs such as fluorouracil",
                    "criterion": "use of oral drugs such as fluorouracil",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. History of severe heart disease;",
            "criterions": [
                {
                    "exact_snippets": "History of severe heart disease",
                    "criterion": "heart disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Long QT, complete left bundle branch block, III degree atrioventricular block;",
            "criterions": [
                {
                    "exact_snippets": "Long QT",
                    "criterion": "Long QT",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "complete left bundle branch block",
                    "criterion": "complete left bundle branch block",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "III degree atrioventricular block",
                    "criterion": "III degree atrioventricular block",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Active autoimmune and inflammatory diseases;",
            "criterions": [
                {
                    "exact_snippets": "Active autoimmune and inflammatory diseases",
                    "criterion": "autoimmune diseases",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "Active autoimmune and inflammatory diseases",
                    "criterion": "inflammatory diseases",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Other malignancies diagnosed within 5 years before the first dose;",
            "criterions": [
                {
                    "exact_snippets": "Other malignancies diagnosed within 5 years before the first dose",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Hypertension poorly controlled by two antihypertensive drugs;",
            "criterions": [
                {
                    "exact_snippets": "Hypertension poorly controlled by two antihypertensive drugs",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled by two antihypertensive drugs"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Patients with poor glycemic control;",
            "criterions": [
                {
                    "exact_snippets": "poor glycemic control",
                    "criterion": "glycemic control",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "poor"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Present with grade ≥2 radiation pneumonitis according to the RTOG/EORTC definition; Previous history of ILD or current ILD, or suspicion of such disease during screening;",
            "criterions": [
                {
                    "exact_snippets": "Present with grade ≥2 radiation pneumonitis according to the RTOG/EORTC definition",
                    "criterion": "radiation pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous history of ILD",
                    "criterion": "interstitial lung disease (ILD)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "current ILD",
                    "criterion": "interstitial lung disease (ILD)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "suspicion of such disease during screening",
                    "criterion": "interstitial lung disease (ILD)",
                    "requirements": [
                        {
                            "requirement_type": "suspicion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;",
            "criterions": [
                {
                    "exact_snippets": "Complicated with pulmonary diseases",
                    "criterion": "pulmonary diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically severe respiratory function impairment",
                    "criterion": "respiratory function impairment",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Active central nervous system metastasis;",
            "criterions": [
                {
                    "exact_snippets": "Active central nervous system metastasis",
                    "criterion": "central nervous system metastasis",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Patients with a history of allergy to recombinant humanized or human-mouse chimeric antibodies or to any of the excipients of BL-B16D1;",
            "criterions": [
                {
                    "exact_snippets": "history of allergy to recombinant humanized or human-mouse chimeric antibodies",
                    "criterion": "allergy to recombinant antibodies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of allergy ... to any of the excipients of BL-B16D1",
                    "criterion": "allergy to excipients of BL-B16D1",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);",
            "criterions": [
                {
                    "exact_snippets": "Received previous organ transplantation",
                    "criterion": "previous organ transplantation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "allogeneic hematopoietic stem cell transplantation (Allo-HSCT)",
                    "criterion": "allogeneic hematopoietic stem cell transplantation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. The cumulative dose of anthracyclines > 360 mg/m2 in previous (new) adjuvant therapy;",
            "criterions": [
                {
                    "exact_snippets": "cumulative dose of anthracyclines > 360 mg/m2",
                    "criterion": "cumulative dose of anthracyclines",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 360,
                                "unit": "mg/m2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;",
            "criterions": [
                {
                    "exact_snippets": "Human immunodeficiency virus antibody positive",
                    "criterion": "HIV antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active tuberculosis",
                    "criterion": "tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active hepatitis B virus infection",
                    "criterion": "hepatitis B virus infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active hepatitis C virus infection",
                    "criterion": "hepatitis C virus infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Severe infection occurred within 4 weeks before the first dose; Signs of pulmonary infection or active pulmonary inflammation within 2 weeks before the first dose;",
            "criterions": [
                {
                    "exact_snippets": "Severe infection occurred within 4 weeks before the first dose",
                    "criterion": "severe infection",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Signs of pulmonary infection or active pulmonary inflammation within 2 weeks before the first dose",
                    "criterion": "pulmonary infection",
                    "requirements": [
                        {
                            "requirement_type": "signs of infection",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Signs of pulmonary infection or active pulmonary inflammation within 2 weeks before the first dose",
                    "criterion": "active pulmonary inflammation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Patients with massive or symptomatic effusions or poorly controlled effusions;",
            "criterions": [
                {
                    "exact_snippets": "massive or symptomatic effusions",
                    "criterion": "effusions",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "massive",
                                "symptomatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "poorly controlled effusions",
                    "criterion": "effusions",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Had participated in another clinical trial within 4 weeks before the first dose;",
            "criterions": [
                {
                    "exact_snippets": "Had participated in another clinical trial within 4 weeks before the first dose",
                    "criterion": "participation in another clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Had the following ocular diseases: a. active infection or corneal ulcer; b. monocular vision; c. a history of corneal transplantation; d. Contact lens dependence; e. Uncontrolled glaucoma; f. Uncontrolled or progressive retinopathy, wet macular degeneration, etc.;",
            "criterions": [
                {
                    "exact_snippets": "active infection or corneal ulcer",
                    "criterion": "ocular disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "active infection",
                                "corneal ulcer"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "monocular vision",
                    "criterion": "ocular disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "monocular vision"
                        }
                    ]
                },
                {
                    "exact_snippets": "a history of corneal transplantation",
                    "criterion": "ocular disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": "corneal transplantation"
                        }
                    ]
                },
                {
                    "exact_snippets": "Contact lens dependence",
                    "criterion": "ocular disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "Contact lens dependence"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled glaucoma",
                    "criterion": "ocular disease",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled glaucoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled or progressive retinopathy, wet macular degeneration, etc.",
                    "criterion": "ocular disease",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled or progressive retinopathy"
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": "wet macular degeneration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Other circumstances that the investigator deemed inappropriate for participation in the trial.",
            "criterions": [
                {
                    "exact_snippets": "Other circumstances that the investigator deemed inappropriate for participation",
                    "criterion": "investigator's discretion",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": "appropriate for participation"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}