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FDA Accepts IND for Arcellx's Multiple Myeloma Cell Therapy

NEW YORK – Arcellx said on Tuesday that the US Food and Drug Administration has accepted its IND application for the autologous T-cell therapy ACLX-001, and that the firm accordingly plans to begin a Phase I clinical trial of Arcellx for multiple myeloma patients in the second half of 2021.

ACLX-001, which Arcellx calls a "controllable and adaptable cell therapy," involves two treatment components, one being engineered autologous "ARC T cells" harvested from the patient, and the other being the SparX proteins that those engineered T cells are engineered to target. The dosage and frequency of the SparX proteins, which are selected specifically to bind to intended tumor antigens, can be adjusted, and because the engineered ARC T cells are manufactured to bind specifically to the SparX proteins, the T cells themselves can be adjusted by way of the proteins. Specific SparX proteins can also be swapped out for different SparX proteins in the case of a cancer recurrence or antigen escape.

The IND clearance for ACLX-001 comes several months after Arcellx presented data from a Phase I trial of its CART-ddBCMA, during which all six relapsed or refractory multiple myeloma patients treated with the therapy responded, and four experienced complete responses. Those results, according to ArcellX, demonstrated the advantages of the binding domain used with the ARC-SparX.

"Building on our Phase I clinical trial where we demonstrated the clinical significance of our novel binding domain in patients suffering from refractory multiple myeloma, ACLX-001 is the next step in validating our differentiated platform," Arcellx CEO Rami Elghandour said in a statement, adding that the company also plans to develop therapies to treat acute myelogenous leukemia and solid tumors.