Anti-CD7 CAR-Engineered T Cells for T Lymphoid Malignancies Malignancies

T Cell Non-Hodgkin Lymphoma Clinical Trial

Official title: Safety and Efficacy of Anti-CD7 CAR-Engineered T Cells for Relapsed/Refractory T Lymphoid Malignancies: a Single-center, Open-label, Non-randomized, Single-arm Clinical Study

Status Recruiting

Clinical Trial Summary

This is a single-center, open-label, single-arm study to evaluate the primary safety and efficacy of anti-CD7 chimeric antigen receptor(CAR)-modified T cells(CAR7-Ts) in patients with relapsed or refractory T lymphoid malignancies.

Clinical Trial Description

Chimeric antigen receptor-T cells (CAR-T) have made breakthroughs in the treatment of B-cell tumors, especially refractory/relapsed acute B lymphocytes. CD7 is a transmembrane glycoprotein expressed by T cells and natural killer cells and their precursors; it is also expressed in >95% of lymphoblastic T-cell leukemias and lymphomas . CD7 was previously evaluated as a target for immunotoxin-loaded antibodies in patients with T-cell malignancies, but tumor responses were limited. Enhancing the potency of CD7-directed cytotoxicity by substituting donor-derived CAR-T cells for a monoclonal antibody would augment the efficacy of CD7-targeted therapy in patients with T-cell malignancies. To prepare CAR7-T cells, CD7 expression is suppressed on donor-derived T cells by unique blocking technique, and CD7-negative T cells are transduced with a humanized anti-CD7-41BB-CD3ζ lentiviral vector. This is an investigational study. The objectives are to evaluate the safety and efficacy of CAR7-T cells in patients with CD7+ T-cell malignancies. ;

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Leukemia, T-Cell
• Lymphoma, T-Cell
• T Cell Non-Hodgkin Lymphoma
• T-Cell Chronic Lymphocytic Leukemia
• T-Cell Lymphocytic Leukemia

• NCT number: NCT04823091
• Study type: Interventional
• Source: Wuhan Union Hospital, China
• Contact: Heng Mei
• Phone: 027-8572600
• Email: hmei@hust.edu.cn
• Status: Recruiting
• Phase: Phase 1
• Start date: April 15, 2021
• Completion date: April 7, 2024