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

Trial Title: CD7 CAR-T Cells in T-cell Lymphoma/Leukemia

NCT ID: NCT05620680

Condition: T Lymphoblastic Leukemia/Lymphoma

Conditions: Official terms:
Lymphoma
Leukemia
Lymphoma, T-Cell

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: CD7 CAR-T cells
Description: patient was subjected to 0.5-2×10^6 cells/kg of CD7 CAR- T
Arm group label: Treatment group

Summary: 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.

Detailed description: T-cell lymphoma accounts for 10%~15% of non-Hodgkin lymphoma in China. According to the World Health Organization (WHO), T-cell lymphoma was divided into the following subtypes: T-cell, NK cell lymphoma/leukemia. There were two major categories: anterior T-cell tumors and posterior thymic T-cell lymphomas, which originate from lymph nodes, extranodal tissue, or skin; mature or peripheral T-cell lymphomas. Generally speaking, the relapse accounts for 50-60% after first-line treatment, while the remission rate with second-line treatment was extremely low. Collectively, there was an urgent need for new treatment modalities to improve the clinical outcomes of these patients. CD7 is a transmembrane glycoprotein that plays an important role in T-cell and T-cell/B-cell interactions during early lymphoid development. The expression of CD7 persist from stem to mature T cells. CD7 was proved to be widely expressed in T-cell malignant, which makes it a promising therapeutic target. In this study we aim to testify the safy and efficacy of CD7 CAR-T cells in T-cell lymphoma/leukemia.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Li Yu

Address:
City: Shenzhen
Zip: 518000
Country: China

Status: Recruiting

Contact:
Last name: Li Yu

Phone: +8675521839178
Email: liyu@vip.163.com

Start date: October 1, 2022

Completion date: October 31, 2028

Lead sponsor:
Agency: Shenzhen University General Hospital
Agency class: Other

Source: Shenzhen University General Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05620680