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confidence high
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materiality 0.65
Caribou Biosciences gets FDA IND clearance for CB-012 allogeneic CAR-T in r/r AML
Caribou Biosciences, Inc.
- FDA cleared IND for CB-012, an allogeneic anti-CLL-1 CAR-T cell therapy for relapsed/refractory AML.
- AMpLify Phase 1 trial planned to start patient enrollment by mid-2024; first dose level at 25×10^6 CAR-T cells.
- CB-012 is the first allogeneic CAR-T with both PD-1 checkpoint disruption and B2M–HLA-E immune cloaking.
- CB-012 is Caribou's third off-the-shelf CAR-T therapy to enter clinical development.
- AML has ~20,380 new US cases in 2023; median survival for r/r AML is typically <7 months.