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U.S. FDA grants fast track designation to CB-012 for the treatment of R/R AML
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On September 3, 2024, the U.S. Food and Drug Administration (FDA) granted fast track designation to CB-012, an allogeneic anti-C-type lectin-like molecule (CLL)-1 chimeric antigen receptor (CAR) T-cell therapy, for the treatment of patients with relapsed/refractory acute myeloid leukemia.1
CB-012 is an allogeneic CAR T-cell therapy that is engineered using clustered regularly interspaced short palindromic repeats (CRISPR) technology and uses checkpoint disruption and immune cloaking to exert antitumor activity.1 CB-012 is currently being investigated in an ongoing phase I trial (AMpLify; NCT06128044).1
- GlobeNewswire. Caribou Biosciences announces the FDA has granted fast track designations to CB-010 in refractory SLE and to CB-012 in relapsed or refractory AML. https://www.globenewswire.com/en/news-release/2024/09/03/2939617/0/en/Caribou-Biosciences-Announces-the-FDA-has-Granted-Fast-Track-Designations-to-CB-010-in-Refractory-SLE-and-to-CB-012-in-Relapsed-or-Refractory-AML.html Published Sep 03, 2024. Accessed Sep 04, 2024.
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