drugset / Trial / NCT04767308

Safety and Efficacy of CT125A Cells for Treatment of Relapsed/Refractory CD5+ Hematopoietic Malignancies

NCT04767308

NaSingle-groupOpen-labelTreatment

Summary

Current treatments for relapsed/refractory hematopoietic malignancies such as B-cell lymphomas (BCLs) and peripheral T-cell lymphomas (PTCLs) are far from satisfactory. CD5 is widely expressed in multiple subtypes of BCLs and PTCLs but rarely found in normal tissues except certain types of lymphocytes. Chimeric antigen receptor (CAR) T cells against CD5 offer another potential therapeutic option for patients with relapsed/refractory CD5 positive hematopoietic malignancies. In the current study, the safety and efficacy of a novel CAR T cell therapy, termed CT125A cells, are evaluated in patients with relapsed/refractory CD5+ hematopoietic malignancies. The endogenous CD5 in CT125A cells is knocked out via CRISPR/Cas9 genome editing technology to prevent fratricide during CAR T cells manufacturing.

Timeline

Start
2021-03
Primary completion
2023-09
Completion
2023-12

Drugs

EvaluationDrugModalityDoseRoute
Subject CT125A cells Cell therapy 1e+06 cells/kg Intravenous
Subject CT125A cells Cell therapy 2e+06 cells/kg Intravenous
Subject CT125A cells Cell therapy 3e+06 cells/kg Intravenous
Background Cyclophosphamide Other / unclassified 500 mg/m2 Intravenous
Background Fludarabine Small molecule 30 mg/m2 Intravenous