Overview

Study of IMPT-314 in R/R Aggressive B-cell

Status:
Not yet recruiting
Trial end date:
2029-12-01
Target enrollment:
Participant gender:
Summary
This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of IMPT-314, a bispecific chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with aggressive B-cell NHL. Up to 30 patients will be enrolled in dose finding Phase 1 part of the study, which will determine the recommended phase 2 dose. Phase 2 will enroll 20 additional participants to evaluate further the safety and efficacy of IMPT-314. IMPT-314 treatment consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a conditioning chemotherapy regimen consisting of fludarabine and cyclophosphamide, administered over 3 days. Individual participants will remain in the active post-treatment period for approximately 2 years. Participants will continue in long-term follow-up for 15 years from treatment.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
ImmPACT Bio