Using CD7 CAR-T cells to treat T-cell lymphoma and leukemia

Study of CD7 CAR-T Cells in Adult Refractory and Recurrent T-cell Lymphoma/Leukemia

This study is testing a new type of treatment using CD7 CAR-T cells to see if it can help adults with T-cell lymphoma and leukemia who haven't had success with other therapies.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shenzhen University General Hospital (Academic / other)
• Drugs / interventions: CAR-T, chemotherapy, radiation
• Locations: 1 site (Shenzhen, Guangdong)
• Trial ID: NCT05620680 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and efficacy of CD7 CAR-T cells in patients with T-cell lymphoma and leukemia, which are known for their high relapse rates and poor prognosis. CD7 is a protein that is widely expressed in T-cell malignancies, making it a promising target for therapy. The trial will involve patients aged 18 to 75 who have relapsed or refractory T-cell lymphoma and have not received certain therapies prior to participation. The goal is to provide a new treatment option that could improve clinical outcomes for these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with relapsed or refractory T-cell lymphoma who meet specific diagnostic criteria.

Not a fit: Patients with a history of allergy to any components of the cell therapy or those who have received antibody therapy within two weeks prior to treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve remission rates and overall survival for patients with T-cell lymphoma and leukemia.

How similar studies have performed: Other studies utilizing CAR-T cell therapies have shown promising results in treating various hematological malignancies, indicating potential success for this approach.

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.

Where this trial is running

Shenzhen, Guangdong

• Li Yu — Shenzhen, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Li Yu, Dr — Shenzhen University General Hospital
• Study coordinator: Yu Li, Dr

Conditions T Lymphoblastic Leukemia/Lymphoma