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

NCT05620680 | Recruiting DMC

• 1 other identifier: HEM-ONCO-017
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

T Lymphoblastic Leukemia/Lymphoma

Outcome Measures

Primary Outcomes (1)

• TEAEs

  Adverse events during treatment

  From date of initial treatment to the 30 days after treatment

Secondary Outcomes (1)

• overall response rate

  baseline and 8 weeks, up to 1 year

Study Arms (1)

Treatment group

EXPERIMENTAL

CD7 CAR-T treatment group

Biological: CD7 CAR-T cells

Interventions

CD7 CAR-T cells BIOLOGICAL

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

Treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 (≥ 18 years old, ≤ 75 years old), gender is not limited;
• The subject voluntarily participates in the research and signs the "Informed Consent" by himself or his legal guardian;
• 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;
• Meet the diagnostic criteria for relapsed/refractory T-cell lymphoma, including any of the following:
• \) 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.

You may not qualify if:

• Those who have a history of allergy to any of the ingredients in cell products;
• 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;
• 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%;
• Abnormal lung function, blood oxygen saturation under indoor air \< 92%;
• Myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other serious clinical heart disease within 12 months before enrollment;
• Grade 3 hypertension with poor control of blood pressure with medication;
• Patients with other advanced tumors (those who are assessed as stable after treatment of other tumors can be enrolled);
• Previous head trauma, impaired consciousness, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease;
• 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;
• Patients with autoimmune diseases, immunodeficiency or other patients requiring immunosuppressant therapy;
• presence of uncontrolled, active infection;
• Have previously used any CAR-T cell product or other genetically modified T cell therapy;
• Live vaccination within 4 weeks prior to enrollment;
• HIV, HBV, HCV and TPPA/RPR infections, and HBV carriers;
• Subject has a history of alcoholism, drug addiction or mental illness;

Sponsors & Collaborators

• Shenzhen University General Hospital: lead

Study Sites (1)

Li Yu

Shenzhen, Guangdong, 518000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Li Yu, Dr

  Shenzhen University General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Li, Dr

CONTACT

+8675521839178; liyu@vip.163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: November 17, 2022
• Study Start: October 1, 2022
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2028
• Last Updated: November 17, 2022

Record last verified: 2022-11

Locations

CN (1)