FDA gives Cellectis IND approval to start clinical trial for AML and BPDCN drug

U.S. Food and Drug Administration (FDA) has granted a French based biopharmaceutical company Cellectis an Investigational New Drug (IND) approval to start first phase clinical trial with UCART123 in patients with acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN)

The company plans to initiate Phase 1 trials in the first half of 2017 at Weill Cornell, by principal investigator Dr. Gail J. Roboz, Director of the Clinical and Translational Leukemia Programs and Professor of Medicine and for BPDCN will be led, at the MD Anderson Cancer Center, by Dr. Naveen Pemmaraju, MD, Assistant Professor, and Professor Hagop Kantarjian, MD, Department Chair, Department of Leukemia, Division of Cancer Medicine.

UCART123 is first “off-the-shelf” gene-edited CAR T-cell product candidate that the FDA has approved for clinical trials. In the

U.S. alone, there are an estimated 19,950 new AML cases per year, with 10,430 estimated deaths per year.


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