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

Launched by SHENZHEN UNIVERSITY GENERAL HOSPITAL · Nov 11, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option called CD7 CAR-T cells for patients with T-cell lymphoma and leukemia, which are types of blood cancers that can be very aggressive and difficult to treat. The goal of the study is to find out if this treatment is safe and effective for patients who have not responded well to other therapies. The trial is currently looking for participants aged 18 to 75 who have been diagnosed with T-cell lymphoma and have experienced a relapse or have not achieved complete remission after initial treatment.

To participate, individuals must be willing to sign an informed consent and meet certain health criteria, such as having no serious heart or lung problems and having an expected survival time of more than three months. Participants can expect to receive the CAR-T cell therapy and will be closely monitored for their safety and how well the treatment works. It's important to note that there are specific conditions that could exclude someone from joining, such as certain allergies, infections, or other serious health issues. If you're considering participating, it’s a good idea to discuss this trial with your healthcare provider to see if it might be a suitable option for you or your loved one.

Gender

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Eligibility criteria

• 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.