{
"info": {
"nct_id": "NCT05489276",
"official_title": "Phase I Clinical Trial of TQB2825 Injection in Subjects With CD20 Positive Hematological Tumors",
"inclusion_criteria": "* 1 Malignant hematologic tumors, including but not limited to lymphoma, leukemia, myeloma, etc., which are clearly diagnosed by histology or cytology (report of immunotyping results is required).\n* 2 Immunophenotypic analysis showed CD20 positive.\n* 3 18 years old ≤ Age ≤75 years old; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.\n* 4 Prior induction or salvage therapy ≥second-line treatment, adequate treatment with at least one regimen containing an anti-CD20 mab (combination chemotherapy or monotherapy), and meeting the following criteria:\n\n 1. Patients who have not been alleviated after the last adequate treatment or whose disease has progressed after remission, or who have relapsed after autologous hematopoietic stem cell transplantation (auto-HSCT)\n 2. Patients with refractory Anti-CD20 monoclonal antibody.\n* 5 According to the 2014 Lugano criteria, there is at least one measurable lesion, that is, a lymph node lesion with a diameter >15 mm or an extranodal lesion with a diameter >10 mm according to the cross-sectional CT image (for tumors with the 2014 Lugano evaluation criteria).\n* 6 Negative serum/urine pregnancy test within 7 days prior to initial dosing and must be non-lactating subjects; Female subjects of reproductive age agree to use contraception (such as an intrauterine device, birth control pill, or condom) during the study period and for six months after the study ends; Male subjects agreed to use contraception during the study period and for six months after the end of the study period.\n* 7 The subjects voluntarily joined the study and signed informed consent with good compliance.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "* 1 Tumor diseases and medical history:\n\n 1. Hematologic malignancies that have or are suspected to involve the central nervous system (CNS) or primary CNS lymphoma;\n 2. Subjects who had or currently had other malignancies within 3 years. Two conditions can be included in clinical trials: five consecutive years of disease-free survival (DFS) for other malignancies treated with a single operation; Cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basal membrane)];\n 3. Clinically significant uncontrolled pleural effusion ascites requiring repeated drainage and pericardial effusion with medium or higher volume.\n* 2 Previous anti-tumor therapy:\n\n 1. Prior treatment with other antibodies targeting both CD3 and CD20;\n 2. Received any investigational antibody drug therapy, CAR T therapy, or other immunocytotherapy, or auto-HSCT within 3 months prior to initial administration;\n 3. Prior allogeneic hematopoietic stem cell transplantation (ALLO-HSCT);\n 4. Any major surgery, chemotherapy and/or radiotherapy, immunotherapy or targeted therapy within 4 weeks prior to initial administration;\n 5. The half-life of the first administration is less than 5 drugs from the previous oral targeted therapy (calculated from the end time of the last treatment);\n 6. Received proprietary Chinese medicines with anticancer indications specified in NMPA approved drug instructions within 2 weeks prior to initial administration;\n 7. The toxicity of previous antitumor treatment is not recovered to ≤ grade 1(common terminology criteria for adverse events 5.0) .\n* 3 Associated diseases and medical history:\n\n 1. Liver abnormalities: decompensated cirrhosis and active hepatitis;\n 2. Renal abnormalities:\n\n I. Renal failure requiring hemodialysis or peritoneal dialysis; II. Previous history of nephrotic syndrome.\n 3. Gastrointestinal abnormalities:\n\n I. Chronic diarrhea persists despite maximum medical treatment; II. Presence of active inflammatory bowel disease within 4 weeks prior to initial administration.\n 4. Cardiovascular and cerebrovascular abnormalities:\n\n I. With or prior history of central nervous system diseases; II. MRI evidence of brain inflammation and/or vasculitis; III. Occurrence of cerebrovascular accident or cerebral infarction within 6 months before the first administration; IV. Arteriovenous thrombosis events such as deep vein thrombosis and pulmonary embolism occurred within 3 months before the first administration; V. With or prior history of cardiovascular disease; VI. Hypertension that cannot be controlled by the combination of the two drugs (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥100 mmHg measured at least twice); VII. Previous or current heart valvulitis or endocarditis.\n 5. Medical history of immunodeficiency: known human immunodeficiency virus (HIV) infection, or other acquired, congenital immunodeficiency disease;\n 6. Uncontrollable systemic bacterial, fungal or viral infection.\n 7. Lung disease:\n\n I. Previous or present with or suspected chronic obstructive pulmonary disease (COPD) and forced expiratory volume at the end of 1 second (FEV1) <60% (estimated value); II. Past or present non-infectious pneumonia requiring corticosteroid treatment; IV. Active tuberculosis.\n 8. History of severe allergies of unknown cause; Known allergy to monoclonal antibodies or to exogenous human immunoglobulin; Known allergy to investigational drug excipients.\n* 4 Getting a live-attenuated vaccine within 4 weeks prior to initial administration or during planned study period.\n* 5 Participated in clinical trials of other drugs within 30 days.\n* 6 It is estimated that the compliance of patients participating in this clinical study is insufficient.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* 1 Malignant hematologic tumors, including but not limited to lymphoma, leukemia, myeloma, etc., which are clearly diagnosed by histology or cytology (report of immunotyping results is required).",
"criterions": [
{
"exact_snippets": "Malignant hematologic tumors, including but not limited to lymphoma, leukemia, myeloma, etc.",
"criterion": "malignant hematologic tumors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "clearly diagnosed by histology or cytology",
"criterion": "diagnosis method",
"requirement": {
"requirement_type": "method",
"expected_value": [
"histology",
"cytology"
]
}
},
{
"exact_snippets": "report of immunotyping results is required",
"criterion": "immunotyping results",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Malignant hematologic tumors, including but not limited to lymphoma, leukemia, myeloma, etc.",
"criterion": "malignant hematologic tumors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "clearly diagnosed by histology or cytology",
"criterion": "diagnosis method",
"requirement": {
"requirement_type": "method",
"expected_value": [
"histology",
"cytology"
]
}
}
]
},
{
"exact_snippets": "report of immunotyping results is required",
"criterion": "immunotyping results",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* 2 Immunophenotypic analysis showed CD20 positive.",
"criterions": [
{
"exact_snippets": "Immunophenotypic analysis showed CD20 positive",
"criterion": "CD20",
"requirement": {
"requirement_type": "presence",
"expected_value": "positive"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Immunophenotypic analysis showed CD20 positive",
"criterion": "CD20",
"requirement": {
"requirement_type": "presence",
"expected_value": "positive"
}
}
]
}
},
{
"identified_line": {
"line": "* 3 18 years old ≤ Age ≤75 years old; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.",
"criterions": [
{
"exact_snippets": "18 years old ≤ Age ≤75 years old",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 75,
"unit": "years"
}
]
}
}
},
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 1,
"unit": "N/A"
}
]
}
}
},
{
"exact_snippets": "Life expectancy ≥ 3 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "18 years old ≤ Age ≤75 years old",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
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"unit": "years"
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{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 1,
"unit": "N/A"
}
]
}
}
},
{
"exact_snippets": "Life expectancy ≥ 3 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* 4 Prior induction or salvage therapy ≥second-line treatment, adequate treatment with at least one regimen containing an anti-CD20 mab (combination chemotherapy or monotherapy), and meeting the following criteria:",
"criterions": [
{
"exact_snippets": "Prior induction or salvage therapy",
"criterion": "prior therapy",
"requirement": {
"requirement_type": "type",
"expected_value": [
"induction",
"salvage"
]
}
},
{
"exact_snippets": "≥second-line treatment",
"criterion": "treatment line",
"requirement": {
"requirement_type": "line",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "line"
}
}
},
{
"exact_snippets": "adequate treatment with at least one regimen containing an anti-CD20 mab",
"criterion": "anti-CD20 mab treatment",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "adequate treatment with at least one regimen containing an anti-CD20 mab",
"criterion": "anti-CD20 mab treatment",
"requirement": {
"requirement_type": "regimen count",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "regimen"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Prior induction or salvage therapy",
"criterion": "prior therapy",
"requirement": {
"requirement_type": "type",
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"salvage"
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}
},
{
"exact_snippets": "≥second-line treatment",
"criterion": "treatment line",
"requirement": {
"requirement_type": "line",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "line"
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}
}
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{
"exact_snippets": "adequate treatment with at least one regimen containing an anti-CD20 mab",
"criterion": "anti-CD20 mab treatment",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
},
{
"exact_snippets": "adequate treatment with at least one regimen containing an anti-CD20 mab",
"criterion": "anti-CD20 mab treatment",
"requirement": {
"requirement_type": "regimen count",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "regimen"
}
}
}
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}
]
}
},
{
"identified_line": {
"line": "1. Patients who have not been alleviated after the last adequate treatment or whose disease has progressed after remission, or who have relapsed after autologous hematopoietic stem cell transplantation (auto-HSCT)",
"criterions": [
{
"exact_snippets": "Patients who have not been alleviated after the last adequate treatment",
"criterion": "response to last adequate treatment",
"requirement": {
"requirement_type": "response",
"expected_value": "not alleviated"
}
},
{
"exact_snippets": "disease has progressed after remission",
"criterion": "disease progression after remission",
"requirement": {
"requirement_type": "progression",
"expected_value": true
}
},
{
"exact_snippets": "relapsed after autologous hematopoietic stem cell transplantation (auto-HSCT)",
"criterion": "relapse after auto-HSCT",
"requirement": {
"requirement_type": "relapse",
"expected_value": true
}
}
]
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"logical_structure": {
"or_criteria": [
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"and_criteria": [
{
"exact_snippets": "Patients who have not been alleviated after the last adequate treatment",
"criterion": "response to last adequate treatment",
"requirement": {
"requirement_type": "response",
"expected_value": "not alleviated"
}
},
{
"exact_snippets": "disease has progressed after remission",
"criterion": "disease progression after remission",
"requirement": {
"requirement_type": "progression",
"expected_value": true
}
}
]
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{
"exact_snippets": "relapsed after autologous hematopoietic stem cell transplantation (auto-HSCT)",
"criterion": "relapse after auto-HSCT",
"requirement": {
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"expected_value": true
}
}
]
}
},
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"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
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"value": 18,
"unit": "Years"
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},
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"identified_line": {
"line": "Must have maximum age of 75 Years",
"criterions": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
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"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
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"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
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"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
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}
}
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"exclusion_lines": [
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"line": "* 1 Tumor diseases and medical history:",
"criterions": [
{
"exact_snippets": "Tumor diseases",
"criterion": "tumor diseases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
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"criterion": "medical history",
"requirement": {
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"expected_value": true
}
}
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"expected_value": true
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}
]
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},
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"identified_line": {
"line": "1. Hematologic malignancies that have or are suspected to involve the central nervous system (CNS) or primary CNS lymphoma;",
"criterions": [
{
"exact_snippets": "Hematologic malignancies that have or are suspected to involve the central nervous system (CNS)",
"criterion": "hematologic malignancies involving CNS",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "primary CNS lymphoma",
"criterion": "primary CNS lymphoma",
"requirement": {
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"expected_value": true
}
}
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"expected_value": true
}
},
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "2. Subjects who had or currently had other malignancies within 3 years. Two conditions can be included in clinical trials: five consecutive years of disease-free survival (DFS) for other malignancies treated with a single operation; Cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basal membrane)];",
"criterions": [
{
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"criterion": "other malignancies",
"requirement": {
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"expected_value": {
"operator": "<=",
"value": 3,
"unit": "years"
}
}
},
{
"exact_snippets": "five consecutive years of disease-free survival (DFS) for other malignancies treated with a single operation",
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"requirement": {
"requirement_type": "duration",
"expected_value": {
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"unit": "years"
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}
},
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"exact_snippets": "five consecutive years of disease-free survival (DFS) for other malignancies treated with a single operation",
"criterion": "disease-free survival for other malignancies",
"requirement": {
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"expected_value": "single operation"
}
},
{
"exact_snippets": "Cured cervical carcinoma in situ",
"criterion": "cervical carcinoma in situ",
"requirement": {
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"expected_value": "cured"
}
},
{
"exact_snippets": "non-melanoma skin cancer",
"criterion": "non-melanoma skin cancer",
"requirement": {
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"expected_value": "cured"
}
},
{
"exact_snippets": "superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basal membrane)]",
"criterion": "superficial bladder tumors",
"requirement": {
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"expected_value": "cured"
}
},
{
"exact_snippets": "superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basal membrane)]",
"criterion": "superficial bladder tumors",
"requirement": {
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"expected_value": [
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"Tis",
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]
}
}
]
},
"logical_structure": {
"condition": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Subjects who had or currently had other malignancies within 3 years",
"criterion": "other malignancies",
"requirement": {
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"expected_value": {
"operator": "<=",
"value": 3,
"unit": "years"
}
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"exact_snippets": "five consecutive years of disease-free survival (DFS) for other malignancies treated with a single operation",
"criterion": "disease-free survival for other malignancies",
"requirement": {
"requirement_type": "duration",
"expected_value": {
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"value": 5,
"unit": "years"
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}
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"exact_snippets": "five consecutive years of disease-free survival (DFS) for other malignancies treated with a single operation",
"criterion": "disease-free survival for other malignancies",
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"expected_value": "single operation"
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"expected_value": "cured"
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{
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"requirement": {
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"expected_value": "cured"
}
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"exact_snippets": "superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basal membrane)]",
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"requirement": {
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]
}
}
]
}
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},
"else_criteria": null
}
},
{
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"criterions": [
{
"exact_snippets": "Clinically significant uncontrolled pleural effusion",
"criterion": "pleural effusion",
"requirement": {
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"expected_value": false
}
},
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"exact_snippets": "Clinically significant uncontrolled pleural effusion",
"criterion": "pleural effusion",
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"expected_value": true
}
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{
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}
},
{
"exact_snippets": "pericardial effusion with medium or higher volume",
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"expected_value": {
"operator": ">=",
"value": 0,
"unit": "medium"
}
}
}
]
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"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Clinically significant uncontrolled pleural effusion",
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"requirement": {
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"expected_value": false
}
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"exact_snippets": "Clinically significant uncontrolled pleural effusion",
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{
"identified_line": {
"line": "* 2 Previous anti-tumor therapy:",
"criterions": [
{
"exact_snippets": "2 Previous anti-tumor therapy",
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"expected_value": {
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"value": 2,
"unit": "N/A"
}
}
}
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"exact_snippets": "2 Previous anti-tumor therapy",
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"expected_value": {
"operator": ">=",
"value": 2,
"unit": "N/A"
}
}
}
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},
{
"identified_line": {
"line": "1. Prior treatment with other antibodies targeting both CD3 and CD20;",
"criterions": [
{
"exact_snippets": "Prior treatment with other antibodies targeting both CD3 and CD20",
"criterion": "prior treatment with antibodies",
"requirement": {
"requirement_type": "targets",
"expected_value": [
"CD3",
"CD20"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Prior treatment with other antibodies targeting both CD3 and CD20",
"criterion": "prior treatment with antibodies",
"requirement": {
"requirement_type": "targets",
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"CD20"
]
}
}
]
}
},
{
"identified_line": {
"line": "2. Received any investigational antibody drug therapy, CAR T therapy, or other immunocytotherapy, or auto-HSCT within 3 months prior to initial administration;",
"criterions": [
{
"exact_snippets": "Received any investigational antibody drug therapy",
"criterion": "investigational antibody drug therapy",
"requirement": {
"requirement_type": "receipt",
"expected_value": true
}
},
{
"exact_snippets": "Received any ... CAR T therapy",
"criterion": "CAR T therapy",
"requirement": {
"requirement_type": "receipt",
"expected_value": true
}
},
{
"exact_snippets": "Received any ... other immunocytotherapy",
"criterion": "other immunocytotherapy",
"requirement": {
"requirement_type": "receipt",
"expected_value": true
}
},
{
"exact_snippets": "Received any ... auto-HSCT",
"criterion": "auto-HSCT",
"requirement": {
"requirement_type": "receipt",
"expected_value": true
}
},
{
"exact_snippets": "within 3 months prior to initial administration",
"criterion": "time since last therapy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Received any investigational antibody drug therapy",
"criterion": "investigational antibody drug therapy",
"requirement": {
"requirement_type": "receipt",
"expected_value": true
}
},
{
"exact_snippets": "within 3 months prior to initial administration",
"criterion": "time since last therapy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Received any ... CAR T therapy",
"criterion": "CAR T therapy",
"requirement": {
"requirement_type": "receipt",
"expected_value": true
}
},
{
"exact_snippets": "within 3 months prior to initial administration",
"criterion": "time since last therapy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Received any ... other immunocytotherapy",
"criterion": "other immunocytotherapy",
"requirement": {
"requirement_type": "receipt",
"expected_value": true
}
},
{
"exact_snippets": "within 3 months prior to initial administration",
"criterion": "time since last therapy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Received any ... auto-HSCT",
"criterion": "auto-HSCT",
"requirement": {
"requirement_type": "receipt",
"expected_value": true
}
},
{
"exact_snippets": "within 3 months prior to initial administration",
"criterion": "time since last therapy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "3. Prior allogeneic hematopoietic stem cell transplantation (ALLO-HSCT);",
"criterions": [
{
"exact_snippets": "Prior allogeneic hematopoietic stem cell transplantation (ALLO-HSCT)",
"criterion": "allogeneic hematopoietic stem cell transplantation",
"requirement": {
"requirement_type": "prior",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Prior allogeneic hematopoietic stem cell transplantation (ALLO-HSCT)",
"criterion": "allogeneic hematopoietic stem cell transplantation",
"requirement": {
"requirement_type": "prior",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "4. Any major surgery, chemotherapy and/or radiotherapy, immunotherapy or targeted therapy within 4 weeks prior to initial administration;",
"criterions": [
{
"exact_snippets": "Any major surgery ... within 4 weeks prior to initial administration",
"criterion": "major surgery",
"requirement": {
"requirement_type": "time since procedure",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
},
{
"exact_snippets": "chemotherapy ... within 4 weeks prior to initial administration",
"criterion": "chemotherapy",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
},
{
"exact_snippets": "radiotherapy ... within 4 weeks prior to initial administration",
"criterion": "radiotherapy",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
},
{
"exact_snippets": "immunotherapy ... within 4 weeks prior to initial administration",
"criterion": "immunotherapy",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
},
{
"exact_snippets": "targeted therapy within 4 weeks prior to initial administration",
"criterion": "targeted therapy",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Any major surgery ... within 4 weeks prior to initial administration",
"criterion": "major surgery",
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"requirement_type": "time since procedure",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "chemotherapy ... within 4 weeks prior to initial administration",
"criterion": "chemotherapy",
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"requirement_type": "time since treatment",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "radiotherapy ... within 4 weeks prior to initial administration",
"criterion": "radiotherapy",
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"requirement_type": "time since treatment",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "immunotherapy ... within 4 weeks prior to initial administration",
"criterion": "immunotherapy",
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"requirement_type": "time since treatment",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "targeted therapy within 4 weeks prior to initial administration",
"criterion": "targeted therapy",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "5. The half-life of the first administration is less than 5 drugs from the previous oral targeted therapy (calculated from the end time of the last treatment);",
"criterions": [
{
"exact_snippets": "The half-life of the first administration is less than 5 drugs from the previous oral targeted therapy",
"criterion": "half-life of the first administration",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<",
"value": 5,
"unit": "drugs"
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "The half-life of the first administration is less than 5 drugs from the previous oral targeted therapy",
"criterion": "half-life of the first administration",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<",
"value": 5,
"unit": "drugs"
}
}
}
}
},
{
"identified_line": {
"line": "6. Received proprietary Chinese medicines with anticancer indications specified in NMPA approved drug instructions within 2 weeks prior to initial administration;",
"criterions": [
{
"exact_snippets": "Received proprietary Chinese medicines with anticancer indications specified in NMPA approved drug instructions within 2 weeks prior to initial administration",
"criterion": "proprietary Chinese medicines with anticancer indications",
"requirement": {
"requirement_type": "time since last administration",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Received proprietary Chinese medicines with anticancer indications specified in NMPA approved drug instructions within 2 weeks prior to initial administration",
"criterion": "proprietary Chinese medicines with anticancer indications",
"requirement": {
"requirement_type": "time since last administration",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "weeks"
}
}
}
]
}
},
{
"identified_line": {
"line": "* 3 Associated diseases and medical history:",
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{
"exact_snippets": "Associated diseases and medical history",
"criterion": "associated diseases and medical history",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
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"exact_snippets": "Associated diseases and medical history",
"criterion": "associated diseases and medical history",
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"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "1. Liver abnormalities: decompensated cirrhosis and active hepatitis;",
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{
"exact_snippets": "Liver abnormalities: decompensated cirrhosis",
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"requirement": {
"requirement_type": "presence",
"expected_value": "decompensated cirrhosis"
}
},
{
"exact_snippets": "Liver abnormalities: ... active hepatitis",
"criterion": "liver abnormalities",
"requirement": {
"requirement_type": "presence",
"expected_value": "active hepatitis"
}
}
]
},
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{
"exact_snippets": "Liver abnormalities: decompensated cirrhosis",
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"requirement_type": "presence",
"expected_value": "decompensated cirrhosis"
}
},
{
"exact_snippets": "Liver abnormalities: ... active hepatitis",
"criterion": "liver abnormalities",
"requirement": {
"requirement_type": "presence",
"expected_value": "active hepatitis"
}
}
]
}
},
{
"identified_line": {
"line": "2. Renal abnormalities:",
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{
"exact_snippets": "Renal abnormalities",
"criterion": "renal abnormalities",
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"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Renal abnormalities",
"criterion": "renal abnormalities",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "I. Renal failure requiring hemodialysis or peritoneal dialysis; II. Previous history of nephrotic syndrome.",
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{
"exact_snippets": "Renal failure requiring hemodialysis or peritoneal dialysis",
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"requirement": {
"requirement_type": "treatment",
"expected_value": [
"hemodialysis",
"peritoneal dialysis"
]
}
},
{
"exact_snippets": "Previous history of nephrotic syndrome",
"criterion": "nephrotic syndrome",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
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"or_criteria": [
{
"exact_snippets": "Renal failure requiring hemodialysis or peritoneal dialysis",
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"hemodialysis",
"peritoneal dialysis"
]
}
},
{
"exact_snippets": "Previous history of nephrotic syndrome",
"criterion": "nephrotic syndrome",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "3. Gastrointestinal abnormalities:",
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{
"exact_snippets": "Gastrointestinal abnormalities",
"criterion": "gastrointestinal abnormalities",
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"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Gastrointestinal abnormalities",
"criterion": "gastrointestinal abnormalities",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "I. Chronic diarrhea persists despite maximum medical treatment; II. Presence of active inflammatory bowel disease within 4 weeks prior to initial administration.",
"criterions": [
{
"exact_snippets": "Chronic diarrhea persists despite maximum medical treatment",
"criterion": "chronic diarrhea",
"requirement": {
"requirement_type": "persistence",
"expected_value": true
}
},
{
"exact_snippets": "Presence of active inflammatory bowel disease within 4 weeks prior to initial administration",
"criterion": "active inflammatory bowel disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Presence of active inflammatory bowel disease within 4 weeks prior to initial administration",
"criterion": "active inflammatory bowel disease",
"requirement": {
"requirement_type": "time frame",
"expected_value": "within 4 weeks prior to initial administration"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Chronic diarrhea persists despite maximum medical treatment",
"criterion": "chronic diarrhea",
"requirement": {
"requirement_type": "persistence",
"expected_value": true
}
},
{
"and_criteria": [
{
"exact_snippets": "Presence of active inflammatory bowel disease within 4 weeks prior to initial administration",
"criterion": "active inflammatory bowel disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Presence of active inflammatory bowel disease within 4 weeks prior to initial administration",
"criterion": "active inflammatory bowel disease",
"requirement": {
"requirement_type": "time frame",
"expected_value": "within 4 weeks prior to initial administration"
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "4. Cardiovascular and cerebrovascular abnormalities:",
"criterions": [
{
"exact_snippets": "Cardiovascular and cerebrovascular abnormalities",
"criterion": "cardiovascular abnormalities",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Cardiovascular and cerebrovascular abnormalities",
"criterion": "cerebrovascular abnormalities",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Cardiovascular and cerebrovascular abnormalities",
"criterion": "cardiovascular abnormalities",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Cardiovascular and cerebrovascular abnormalities",
"criterion": "cerebrovascular abnormalities",
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"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "I. With or prior history of central nervous system diseases; II. MRI evidence of brain inflammation and/or vasculitis; III. Occurrence of cerebrovascular accident or cerebral infarction within 6 months before the first administration; IV. Arteriovenous thrombosis events such as deep vein thrombosis and pulmonary embolism occurred within 3 months before the first administration; V. With or prior history of cardiovascular disease; VI. Hypertension that cannot be controlled by the combination of the two drugs (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥100 mmHg measured at least twice); VII. Previous or current heart valvulitis or endocarditis.",
"criterions": [
{
"exact_snippets": "With or prior history of central nervous system diseases",
"criterion": "central nervous system diseases",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "MRI evidence of brain inflammation and/or vasculitis",
"criterion": "brain inflammation and/or vasculitis",
"requirement": {
"requirement_type": "evidence",
"expected_value": true
}
},
{
"exact_snippets": "Occurrence of cerebrovascular accident or cerebral infarction within 6 months before the first administration",
"criterion": "cerebrovascular accident or cerebral infarction",
"requirement": {
"requirement_type": "occurrence",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
},
{
"exact_snippets": "Arteriovenous thrombosis events such as deep vein thrombosis and pulmonary embolism occurred within 3 months before the first administration",
"criterion": "arteriovenous thrombosis events",
"requirement": {
"requirement_type": "occurrence",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
},
{
"exact_snippets": "With or prior history of cardiovascular disease",
"criterion": "cardiovascular disease",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "Hypertension that cannot be controlled by the combination of the two drugs (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥100 mmHg measured at least twice)",
"criterion": "hypertension",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
},
{
"exact_snippets": "Hypertension that cannot be controlled by the combination of the two drugs (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥100 mmHg measured at least twice)",
"criterion": "hypertension",
"requirement": {
"requirement_type": "systolic blood pressure",
"expected_value": {
"operator": ">=",
"value": 160,
"unit": "mmHg"
}
}
},
{
"exact_snippets": "Hypertension that cannot be controlled by the combination of the two drugs (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥100 mmHg measured at least twice)",
"criterion": "hypertension",
"requirement": {
"requirement_type": "diastolic blood pressure",
"expected_value": {
"operator": ">=",
"value": 100,
"unit": "mmHg"
}
}
},
{
"exact_snippets": "Previous or current heart valvulitis or endocarditis",
"criterion": "heart valvulitis or endocarditis",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Hypertension that cannot be controlled by the combination of the two drugs (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥100 mmHg measured at least twice)",
"criterion": "hypertension",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
},
{
"exact_snippets": "Hypertension that cannot be controlled by the combination of the two drugs (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥100 mmHg measured at least twice)",
"criterion": "hypertension",
"requirement": {
"requirement_type": "systolic blood pressure",
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"operator": ">=",
"value": 160,
"unit": "mmHg"
}
}
},
{
"exact_snippets": "Hypertension that cannot be controlled by the combination of the two drugs (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥100 mmHg measured at least twice)",
"criterion": "hypertension",
"requirement": {
"requirement_type": "diastolic blood pressure",
"expected_value": {
"operator": ">=",
"value": 100,
"unit": "mmHg"
}
}
}
]
},
{
"exact_snippets": "With or prior history of central nervous system diseases",
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"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "MRI evidence of brain inflammation and/or vasculitis",
"criterion": "brain inflammation and/or vasculitis",
"requirement": {
"requirement_type": "evidence",
"expected_value": true
}
},
{
"exact_snippets": "Occurrence of cerebrovascular accident or cerebral infarction within 6 months before the first administration",
"criterion": "cerebrovascular accident or cerebral infarction",
"requirement": {
"requirement_type": "occurrence",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
},
{
"exact_snippets": "Arteriovenous thrombosis events such as deep vein thrombosis and pulmonary embolism occurred within 3 months before the first administration",
"criterion": "arteriovenous thrombosis events",
"requirement": {
"requirement_type": "occurrence",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
},
{
"exact_snippets": "With or prior history of cardiovascular disease",
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"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "Previous or current heart valvulitis or endocarditis",
"criterion": "heart valvulitis or endocarditis",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "5. Medical history of immunodeficiency: known human immunodeficiency virus (HIV) infection, or other acquired, congenital immunodeficiency disease;",
"criterions": [
{
"exact_snippets": "Medical history of immunodeficiency: known human immunodeficiency virus (HIV) infection",
"criterion": "HIV infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Medical history of immunodeficiency: ... other acquired, congenital immunodeficiency disease",
"criterion": "immunodeficiency disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Medical history of immunodeficiency: known human immunodeficiency virus (HIV) infection",
"criterion": "HIV infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Medical history of immunodeficiency: ... other acquired, congenital immunodeficiency disease",
"criterion": "immunodeficiency disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "6. Uncontrollable systemic bacterial, fungal or viral infection.",
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{
"exact_snippets": "Uncontrollable systemic bacterial, fungal or viral infection.",
"criterion": "systemic bacterial infection",
"requirement": {
"requirement_type": "controllability",
"expected_value": "uncontrollable"
}
},
{
"exact_snippets": "Uncontrollable systemic bacterial, fungal or viral infection.",
"criterion": "systemic fungal infection",
"requirement": {
"requirement_type": "controllability",
"expected_value": "uncontrollable"
}
},
{
"exact_snippets": "Uncontrollable systemic bacterial, fungal or viral infection.",
"criterion": "systemic viral infection",
"requirement": {
"requirement_type": "controllability",
"expected_value": "uncontrollable"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Uncontrollable systemic bacterial, fungal or viral infection.",
"criterion": "systemic bacterial infection",
"requirement": {
"requirement_type": "controllability",
"expected_value": "uncontrollable"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Uncontrollable systemic bacterial, fungal or viral infection.",
"criterion": "systemic fungal infection",
"requirement": {
"requirement_type": "controllability",
"expected_value": "uncontrollable"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Uncontrollable systemic bacterial, fungal or viral infection.",
"criterion": "systemic viral infection",
"requirement": {
"requirement_type": "controllability",
"expected_value": "uncontrollable"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "7. Lung disease:",
"criterions": [
{
"exact_snippets": "Lung disease",
"criterion": "lung disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Lung disease",
"criterion": "lung disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "I. Previous or present with or suspected chronic obstructive pulmonary disease (COPD) and forced expiratory volume at the end of 1 second (FEV1) <60% (estimated value); II. Past or present non-infectious pneumonia requiring corticosteroid treatment; IV. Active tuberculosis.",
"criterions": [
{
"exact_snippets": "Previous or present with or suspected chronic obstructive pulmonary disease (COPD)",
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}
},
{
"exact_snippets": "forced expiratory volume at the end of 1 second (FEV1) <60%",
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"value": 60,
"unit": "%"
}
}
},
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"exact_snippets": "Past or present non-infectious pneumonia requiring corticosteroid treatment",
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"expected_value": true
}
},
{
"exact_snippets": "Past or present non-infectious pneumonia requiring corticosteroid treatment",
"criterion": "non-infectious pneumonia",
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"expected_value": "corticosteroid"
}
},
{
"exact_snippets": "Active tuberculosis",
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}
}
]
},
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{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Previous or present with or suspected chronic obstructive pulmonary disease (COPD)",
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}
},
{
"exact_snippets": "forced expiratory volume at the end of 1 second (FEV1) <60%",
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"value": 60,
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}
}
}
]
}
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{
"and_criteria": [
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"exact_snippets": "Past or present non-infectious pneumonia requiring corticosteroid treatment",
"criterion": "non-infectious pneumonia",
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}
},
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}
}
]
},
{
"exact_snippets": "Active tuberculosis",
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}
}
]
}
},
{
"identified_line": {
"line": "* 4 Getting a live-attenuated vaccine within 4 weeks prior to initial administration or during planned study period.",
"criterions": [
{
"exact_snippets": "Getting a live-attenuated vaccine within 4 weeks prior to initial administration",
"criterion": "live-attenuated vaccine",
"requirement": {
"requirement_type": "time since administration",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
}
]
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"exact_snippets": "Getting a live-attenuated vaccine within 4 weeks prior to initial administration",
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"requirement_type": "time since administration",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
}
}
},
{
"identified_line": {
"line": "* 5 Participated in clinical trials of other drugs within 30 days.",
"criterions": [
{
"exact_snippets": "Participated in clinical trials of other drugs within 30 days.",
"criterion": "participation in other clinical trials",
"requirement": {
"requirement_type": "time since last participation",
"expected_value": {
"operator": "<=",
"value": 30,
"unit": "days"
}
}
}
]
},
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"exact_snippets": "Participated in clinical trials of other drugs within 30 days.",
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"expected_value": {
"operator": "<=",
"value": 30,
"unit": "days"
}
}
}
}
},
{
"identified_line": {
"line": "* 6 It is estimated that the compliance of patients participating in this clinical study is insufficient.",
"criterions": [
{
"exact_snippets": "compliance of patients participating in this clinical study is insufficient",
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"requirement": {
"requirement_type": "sufficiency",
"expected_value": false
}
}
]
},
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"exact_snippets": "compliance of patients participating in this clinical study is insufficient",
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"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "8. History of severe allergies of unknown cause; Known allergy to monoclonal antibodies or to exogenous human immunoglobulin; Known allergy to investigational drug excipients.",
"criterions": [
{
"exact_snippets": "History of severe allergies of unknown cause",
"criterion": "severe allergies",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of severe allergies of unknown cause",
"criterion": "severe allergies",
"requirement": {
"requirement_type": "cause",
"expected_value": "unknown"
}
},
{
"exact_snippets": "Known allergy to monoclonal antibodies",
"criterion": "allergy to monoclonal antibodies",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Known allergy to exogenous human immunoglobulin",
"criterion": "allergy to exogenous human immunoglobulin",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Known allergy to investigational drug excipients",
"criterion": "allergy to investigational drug excipients",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "History of severe allergies of unknown cause",
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"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of severe allergies of unknown cause",
"criterion": "severe allergies",
"requirement": {
"requirement_type": "cause",
"expected_value": "unknown"
}
}
]
},
{
"exact_snippets": "Known allergy to monoclonal antibodies",
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"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Known allergy to exogenous human immunoglobulin",
"criterion": "allergy to exogenous human immunoglobulin",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "Known allergy to investigational drug excipients",
"criterion": "allergy to investigational drug excipients",
"requirement": {
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}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "2. Patients with refractory Anti-CD20 monoclonal antibody.",
"criterions": [
{
"exact_snippets": "refractory Anti-CD20 monoclonal antibody",
"criterion": "Anti-CD20 monoclonal antibody",
"requirement": {
"requirement_type": "refractory",
"expected_value": true
}
}
]
},
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}
}
},
{
"identified_line": {
"line": "* 5 According to the 2014 Lugano criteria, there is at least one measurable lesion, that is, a lymph node lesion with a diameter >15 mm or an extranodal lesion with a diameter >10 mm according to the cross-sectional CT image (for tumors with the 2014 Lugano evaluation criteria).",
"criterions": [
{
"exact_snippets": "at least one measurable lesion, that is, a lymph node lesion with a diameter >15 mm",
"criterion": "lymph node lesion",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">",
"value": 15,
"unit": "mm"
}
}
},
{
"exact_snippets": "at least one measurable lesion, that is, ... an extranodal lesion with a diameter >10 mm",
"criterion": "extranodal lesion",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">",
"value": 10,
"unit": "mm"
}
}
}
]
},
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}
}
},
{
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"line": "* 6 Negative serum/urine pregnancy test within 7 days prior to initial dosing and must be non-lactating subjects; Female subjects of reproductive age agree to use contraception (such as an intrauterine device, birth control pill, or condom) during the study period and for six months after the study ends; Male subjects agreed to use contraception during the study period and for six months after the end of the study period.",
"criterions": [
{
"exact_snippets": "Negative serum/urine pregnancy test",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
},
{
"exact_snippets": "within 7 days prior to initial dosing",
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}
},
{
"exact_snippets": "must be non-lactating subjects",
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}
},
{
"exact_snippets": "Female subjects of reproductive age agree to use contraception",
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}
},
{
"exact_snippets": "during the study period and for six months after the study ends",
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}
},
{
"exact_snippets": "Male subjects agreed to use contraception",
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}
},
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"exact_snippets": "during the study period and for six months after the end of the study period",
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}
}
]
},
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}
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},
{
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"line": "* 7 The subjects voluntarily joined the study and signed informed consent with good compliance.",
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"exact_snippets": "voluntarily joined the study",
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}
},
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"exact_snippets": "signed informed consent",
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}
},
{
"exact_snippets": "good compliance",
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},
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}
},
{
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"line": "Healthy volunteers allowed",
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"exact_snippets": "Healthy volunteers allowed",
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}
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}
],
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{
"identified_line": {
"line": "7. The toxicity of previous antitumor treatment is not recovered to ≤ grade 1(common terminology criteria for adverse events 5.0) .",
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"exact_snippets": "toxicity of previous antitumor treatment is not recovered to ≤ grade 1",
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"operator": "<=",
"value": 1,
"unit": "grade"
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}
}
]
},
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"exact_snippets": "toxicity of previous antitumor treatment is not recovered to \u0010 grade 1",
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"value": 1,
"unit": "grade"
}
}
}
}
}
],
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}