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FDA clears investigational new drug application for ALLO-605 for multiple myeloma

Apr 21, 2021

On April 19, 2021, it was announced that the U.S. Food and Drug Administration (FDA) cleared an investigational new drug (IND) application for ALLO-605 for the treatment of relapsed/refractory multiple myeloma.1 ALLO-605 is an allogeneic chimeric antigen receptor (CAR) T-cell therapy targeting the B-cell maturation antigen (BCMA).

Besides their anti-BCMA effect, ALLO-605 cells co-express a constitutively active chimeric cytokine receptor or turbodomain, which provides CAR T-cell intrinsic cytokine signaling. Preclinical studies found that the ALLO-605 design could recapitulate cytokine signaling to control T cell exhaustion, reduce rejection, and improve T cell function and potency to reduce the dose of T cells needed.1,2

This IND clearance allows for the commencement of the phase I IGNITE trial, due to start later this year, which will evaluate escalating doses of ALLO-605.1

For more information on anti-BCMA allogeneic CAR T cells, read our article here.

  1. Allogene Therapeutics. Allogene Therapeutics Receives IND Clearance from the U.S. Food and Drug Administration for ALLO-605, the First TurboCAR™ Candidate, for the Treatment of Patients with Relapsed/Refractory Multiple Myeloma. Published Apr 19, 2021. Accessed Apr 20, 2021.
  2. Allogene Therapeutics. TurboCAR™: Turbocharging CAR T cells. Accessed Apr 20, 2021.