Kite, a Gilead Company, and Arcellx have announced plans to commence a Phase III clinical trial of anitocabtagene autoleucel (anito-cel), for treating multiple myeloma.
Anito-cel is a B-cell maturation antigen chimeric antigen receptor (BCMA CAR) T-cell therapy.
The development is part of various operational updates announced by the companies on their partnered anito-cel multiple myeloma programme.
Dubbed iMMagine-3, the randomised, controlled, global study will assess anito-cel's efficacy and safety against the standard of care in patients with relapsed and/or refractory multiple myeloma (r/r MM) who have undergone one to three treatments previously.
It will enrol nearly 450 adults across 130 study sites in North America, Europe, and other regions.
Progression-free survival is the primary endpoint of the trial while complete response rate, overall survival, minimal residual disease negativity, and safety will be the secondary endpoints.
Kite anticipates commencing the iMMagine-3 trial in the second half of 2024.
A Kite facility in Frederick, Maryland, US, is designated to produce anito-cel for this trial.
This development marks a significant milestone following the technical transfer from a third-party contract manufacturer and the transfer of the US Food and Drug Administration-cleared investigational new drug application.
The strategic collaboration between Arcellx and Kite encompasses anito-cel’s joint development and commercialisation in the US, with Kite handling marketing internationally.
Kite executive vice-president Cindy Perettie said: “We are pleased to start the Phase III pivotal trial, iMMagine-3, in the second half of this year given the tremendous unmet need that remains in patients with relapsed and/or refractory multiple myeloma.
“As we prepare for this pivotal programme, we look forward to leveraging our manufacturing expertise to further position anito-cel as a potential best-in-class cell therapy. We know manufacturing quality, reliability and speed are critically important as every day matters for these patients.”
In September 2023, Kite published Phase II data for Yescarta (axicabtagene ciloleucel) for treating relapsed/refractory large B-cell lymphoma.
