WASHINGTON D.C. – The FDA has cleared Arcellx to resume its iMMagine-1 Phase II clinical program for its CART-ddBCMA treatment following a partial clinical hold. This treatment is for patients with relapsed or refractory multiple myeloma.
The trial, which is being carried out in collaboration with Gilead’s Kite Pharma, had been put on hold in June after a participant who received the investigational cell therapy passed away. However, Arcellx revealed that this particular patient was actually ineligible for the treatment under the trial protocol and was subsequently managed in a way that conflicted with that protocol. The company has retrained the clinical sites involved in the study and made further adjustments to prevent such lapses from reoccurring.
“We have worked closely with FDA to expeditiously resolve the clinical hold and we thank them for their collaboration and dialogue throughout this process,” said Arcellx CEO Rami Elghandour in the company’s press release.
The company expects preliminary data from the trial in the second half of 2024.
Following the death of a patient, the FDA had initially placed a clinical hold on Arcellx’s iMMagine-1 Phase II trial of its T cell therapy for relapsed or refractory multiple myeloma. The company’s stock fell around 23% in pre-market trading after this announcement.
Arcellx contends that “limitations” on the bridging therapy “are a contributing factor” and is working with the agency to amend the protocol and expand patient options, according to a recent press release. The FDA has given the go-ahead to dose the patients who have already undergone lymphodepletion in the trial, the company said.
Arcellx’s CART-ddBCMA cell therapy is being co-developed by Kite Pharma, a Gilead company, under a $225 million deal. The investigational cell therapy utilizes the former’s novel BCMA-targeted binding domain.
In conclusion, the FDA has cleared Arcellx to continue testing its CART-ddBCMA treatment for patients with relapsed or refractory multiple myeloma. This comes after a partial clinical hold was placed on the trial in June due to the death of a participant. The company has made adjustments and retrained the clinical sites to prevent such issues from happening again. The company expects to provide preliminary data from the trial in the second half of 2024.