CD7 CAR-T Cells in T-cell Lymphoma/Leukemia
T Lymphoblastic Leukemia/Lymphoma
About this trial
This is an interventional treatment trial for T Lymphoblastic Leukemia/Lymphoma
Eligibility Criteria
Inclusion Criteria: Age 18-75 (≥ 18 years old, ≤ 75 years old), gender is not limited; The subject voluntarily participates in the research and signs the "Informed Consent" by himself or his legal guardian; According to the National Comprehensive Cancer Network (NCCN) T lymphocytic lymphoma (2020.V1)/acute lymphoblastic leukemia (2020. V1) practice guidelines, diagnosed with T-cell lymphoma; Meet the diagnostic criteria for relapsed/refractory T-cell lymphoma, including any of the following: 1) Failure to obtain CR at the end of induction therapy; 2) Patients who have obtained CR have blasts in peripheral blood or bone marrow (proportion >5%), or extramedullary diseases; 5. Have not received antibody therapy within 2 weeks before cell therapy; 6. ECOG score of 0-2; 7. The subject has no contraindications to peripheral apheresis; 8. Expected survival time of more than 3 months. Exclusion Criteria: Those who have a history of allergy to any of the ingredients in cell products; Laboratory tests for the following: including but not limited to, total serum bilirubin≧ 1.5mg/dl; Serum ALT or AST greater than 2.5 times the upper limit of normal; Blood creatinine≧ 2.0mg/dl; Platelet count≦ 10×109/L; Patients with cardiac insufficiency who belong to class III or IV according to the New York Cardiology Association (NYHA) cardiac function grading standards; or echocardiography with left ventricular ejection fraction (LVEF) < 50%; Abnormal lung function, blood oxygen saturation under indoor air < 92%; Myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other serious clinical heart disease within 12 months before enrollment; Grade 3 hypertension with poor control of blood pressure with medication; Patients with other advanced tumors (those who are assessed as stable after treatment of other tumors can be enrolled); Previous head trauma, impaired consciousness, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease; Known central nervous system leukemia (CNS2 or CNS3), resistance to intrathecal chemotherapy injections and/or ongoing head and/or spinal radiation therapy; Previous CNS history but has been effectively controlled to allow enrollment; Patients with autoimmune diseases, immunodeficiency or other patients requiring immunosuppressant therapy; presence of uncontrolled, active infection; Have previously used any CAR-T cell product or other genetically modified T cell therapy; Live vaccination within 4 weeks prior to enrollment; HIV, HBV, HCV and TPPA/RPR infections, and HBV carriers; Subject has a history of alcoholism, drug addiction or mental illness; The subject has participated in any other clinical research within 3 months before joining this clinical study; Female subjects have any of the following conditions: a) are pregnant/lactating; or b) have plans to become pregnant during the trial; or c) are of childbearing potential and unable to use effective contraception; There are other circumstances in which the investigator believes that the subject is not suitable for this study.
Sites / Locations
- Li YuRecruiting
Arms of the Study
Arm 1
Experimental
Treatment group
CD7 CAR-T treatment group