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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Li Yu
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Principal investigator: Li Yu, Dr — Shenzhen University General Hospital
• Study coordinator: Yu Li, Dr
• Email: liyu@vip.163.com
• Phone: +8675521839178

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Loncastuximab tesirine plus rituximab as bridging therapy before CAR-T for relapsed or refractory large B‑cell lymphoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.