Arcellx's lead product candidate, CART-ddBCMA, is being developed for the treatment of relapsed or refractory multiple myeloma (r/r MM) in an ongoing Phase II study. CART-ddBCMA has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations by the US Food and Drug Administration.

The Californian company is also advancing its dosable and controllable CAR-T therapy, ARC-SparX, through two programs: a Phase I study of ACLX-001 for r/r MM, initiated in the second quarter of 2022; and ACLX-002 in r/r acute myeloid leukemia and high-risk myelodysplastic syndrome, initiated in the fourth quarter of 2022.

In December 2022, Arcellx has entered a global strategic collaboration to co-develop and co-commercialize CART-ddBCMA with Gilead Sciences’ Kite unit.