TRAC Locus-inserted CD19-targeting STAR-T Cell Therapy in r/r B-NHL
Status:
Recruiting
Trial end date:
2025-12-15
Target enrollment:
Participant gender:
Summary
The team has developed a chimeric antigen receptor (CAR) based on T cell receptor (TCR)
complex, called synthetic TCR and antigen receptor (STAR). Further, the researchers disrupted
the endogenous T-cell receptor α constant (TRAC) locus by CRISPR/cas9, and then knocked in
the anti-CD19-STAR construct through TRAC endogenous promoter. In this single center,
prospective, open-label, single-arm, phase 1/2 study, the safety and efficacy of autologous
CD19-targeting STAR-T cell therapy will be evaluated in patients with relapsed or refractory
(r/r) B-cell non-Hodgkin's lymphoma (B-NHL) . A total of 19 to 38 patients are planned to be
enrolled and receive CD19-STAR-T cell infusion. Phase 1 (9 to 18 cases) is dose escalation
part, and phase 2 (10 to 20 cases) is expansion cohort part.