Allogenic CD19-targeting CAR-γδT Cell Therapy in r/r NHL
Status:
Recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
Summary
CD19-CAR-γδT cell therapy is a cellular immunotherapy targeting CD19 to perform CAR
modification on allogeneic γδT cells. In this study, a second-generation anti-CD19 CAR
prototype was constructed, bearing murine FMC63 single-chain variant fragment (scFv) together
with intracellular 4-1BB co-stimulatory and CD3ζ signaling domains linked by a CD8α sequence
comprising the hinge and transmembrane domains. The cells were derived from the patient's
relative donors or unrelated healthy donors. Human leukocyte antigen (HLA) -mismatched or
partially matched or full matched are acceptable.
This is a single center, prospective, open-label, single-arm, phase 1/2 study. A total of
around 30 patients with relapsed or refractory (r/r) B-cell non-Hodgkin's lymphoma (NHL) will
be enrolled in the study and receive allogeneic CD19-CAR-γδT cell infusion. Phase 1 (n=12 to
15) is dose escalation part, and phase 2 (n=15) is expansion cohort part. The primary
objective of this study was to evaluate the safety and efficacy of allogeneic CD19-CAR-γδT
cell therapy in patients with r/r B-cell NHL.