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CD7 CAR-T Cells in T-cell Lymphoma/Leukemia

RecruitingNAAges 18 Years - 75 YearsAllShenzhen University General Hospital
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In plain words

What the trial is, and whether it could suit you

T-cell lymphoma/leukemia is a group of highly lethal diseases with a high relapse rate and poor prognosis. CD7 was proved to be widely expressed in T-cell malignant, which makes it a promising therapeutic target. In this study we aim to test the safety and efficacy of CD7 CAR-T cells in T-cell lymphoma/leukemia.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age 18-75 (≥ 18 years old, ≤ 75 years old), gender is not limited; 2. The subject voluntarily participates in the research and signs the "Informed Consent" by himself or his legal guardian; 3. 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; 4. 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: 1. Those who have a history of allergy to any of the ingredients in cell products; 2. 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; 3. 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%; 4. Abnormal lung function, blood oxygen saturation under indoor air \< 92%; 5. Myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other serious clinical heart disease within 12 months before enrollment; 6. Grade 3 hypertension with poor control of blood pressure with medication; 7. Patients with other advanced tumors (those who are assessed as stable after treatment of other tumors can be enrolled); 8. Previous head trauma, impaired consciousness, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease; 9. 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; 10. Patients with autoimmune diseases, immunodeficiency or other patients requiring immunosuppressant therapy; 11. presence of uncontrolled, active infection; 12. Have previously used any CAR-T cell product or other genetically modified T cell therapy; 13. Live vaccination within 4 weeks prior to enrollment; 14. HIV, HBV, HCV and TPPA/RPR infections, and HBV carriers; 15. Subject has a history of alcoholism, drug addiction or mental illness; 16. The subject has participated in any other clinical research within 3 months before joining this clinical study; 17. 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; 18. There are other circumstances in which the investigator believes that the subject is not suitable for this study.
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What it tests

  • CD7 CAR-T cells
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Where

1 site
Li Yu
Shenzhen, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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