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

NCT ID: NCT05620680

Last Updated: 2022-11-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2028-10-31

Brief 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.

Conditions

T Lymphoblastic Leukemia/Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

CD7 CAR-T treatment group

Group Type: EXPERIMENTAL

CD7 CAR-T cells

Intervention Type: BIOLOGICAL

patient was subjected to 0.5-2×10\^6 cells/kg of CD7 CAR- T

Interventions

CD7 CAR-T cells

patient was subjected to 0.5-2×10\^6 cells/kg of CD7 CAR- T

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen University General Hospital

OTHER

Sponsor Role: lead

Responsible Party

YuLi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li Yu, Dr

Role: PRINCIPAL_INVESTIGATOR

Shenzhen University General Hospital

Locations

Li Yu

Shenzhen, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yu Li, Dr

Role: CONTACT

liyu@vip.163.com

+8675521839178

Facility Contacts

Li Yu

Role: primary

liyu@vip.163.com

+8675521839178

Other Identifiers

HEM-ONCO-017

Identifier Type: -

Identifier Source: org_study_id