Weekly Digest - 13-19 May 2023
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
Weekly Digest - 13-19 May 2023
May 15, 2023: IMPT-314 (IV) / R/R Aggressive B Cell Lymphoma / ImmPACT Bio: Received Fast Track Designation
- FDA granted a Fast Track Designation for IMPT-314 a potential first-in-class CD19/CD20 CAR T therapy for R/R Aggressive B Cell Lymphoma
- Key safety and efficacy highlights from the Phase 1 study:
- ORR: 91%, DOR: 73%
- mPFS: 18.2 months
- No neurotoxicity and cytokine release syndrome above Grade 1
- Upcoming milestones:
- Dosing of the first patient in the Phase 1/2 trial is expected in Q2 2023
- Initial Phase 1 safety and efficacy data expected in the H2 2023
- “Fast track designation from the FDA underscores the serious unmet medical need in patients with aggressive B cell lymphomas and reinforces the differentiated therapeutic promise of IMPT-314,” said Sumant Ramachandra, M.D., Ph.D., President and CEO of ImmPACT Bio
