Caribou gets RMAT designation from FDA for CB-011 in relapsed/refractory multiple myeloma

Caribou Biosciences, Inc.

FDA grants Regenerative Medicine Advanced Therapy (RMAT) designation for CB-011 allogeneic anti-BCMA CAR-T.
RMAT based on CaMMouflage phase 1 dose escalation data: 92% ORR, 75% ≥CR, 91% MRD negativity in 12 BCMA-naïve patients at RDE.
No graft-versus-host disease or certain neurotoxicities observed; manageable safety profile reported.
Dose expansion enrollment ongoing for both BCMA-naïve and BCMA-exposed cohorts; additional data expected in 2026.

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