NEW YORK – Gilead Sciences' Kite and Arcellx on Thursday provided details on the design of an upcoming Phase III clinical study testing their autologous cell therapy anitocabtagene autoleucel in multiple myeloma patients.
In the iMMagine-3 trial, Kite and Arcellx, which are jointly developing anito-cel, will compare the activity of the autologous, B-cell maturation antigen (BCMA)-directed CAR T-cell therapy against investigator's choice of standard-of-care therapy in roughly 450 patients with previously treated, relapsed or refractory multiple myeloma.
To be eligible for the trial, which is expected to begin during the second half of this year and take place at roughly 130 global sites, patients must have one to three prior treatments, including an immunomodulatory drug and an anti-CD38 monoclonal antibody. Kite and Arcellx will evaluate patients' progression-free survival as the primary endpoint. Secondary endpoints include patients' complete response rates, minimal residual disease negativity, overall survival, and safety.
With the completion of a technical transfer from a third-party contract manufacturing organization, Kite can manufacture the autologous CAR T-cell therapy at its central manufacturing facility in Frederick, Maryland.
Separately, Kite and Arcellx said on Thursday that they are still on track to present preliminary data from the Phase II iMMagine-1 trial of anito-cel by the end of the year.
Anito-cel, which Kite and Arcellx call a CART-ddBCMA, involves harvesting patients' immune cells, then using Arcellx's D-Domain binder to modify the T cells to target BCMA on the surface of multiple myeloma cells. Although other BCMA-targeted autologous CAR T-cell therapies have already been approved for treating relapsed or refractory multiple myeloma, including Janssen and Legend Biotech's Carvykti (ciltacabtagene autoleucel) and Bristol Myers Squibb and 2seventy Bio's Abecma (idecabtagene vicleucel), anito-cel is the first cell therapy being developed in this setting using a novel and compact D-Domain binder.