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Allogene Therapeutics, Inc. (NASDAQ:ALLO) on Friday said it has selected standard fludarabine and cyclophosphamide (FC) as the lymphodepletion regimen to be used in its ALPHA3 study evaluating cemacabtagene ansegedleucel (cema-cel) in first-line consolidation for large B-cell lymphoma (LBCL).
The arm testing FC plus ALLO-647, an anti-CD52 mAb (FCA), is now closed to further enrollment.
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The decision, made ahead of the scheduled futility analysis, was prompted by a Grade 5 adverse event (patient death) in the FC plus ALLO-647 arm that has been attributed to the use of ALLO-647.
The event occurred on Day 54 post-infusion from hepatic failure, believed to have resulted from disseminated adenovirus infection in the setting of immune suppression.
The company on Friday said the event was deemed unrelated to cema-cel. Severe viral infections have been rare across Allogene’s clinical trials. However, when present, they have been attributed to immunosuppression due in part to ALLO-647.
There have been no cases of adenoviral infection or hepatic failure in any participant treated with FC lymphodepletion across Allogene’s trials.
Adopting standard FC in the ALPHA3 trial marks a key shift in Allogene’s clinical strategy.
As a result, no trials are open to enrollment or pipeline programs, including ALLO-647.
Instead, the company is advancing its next-generation AlloCAR T product candidates using the proprietary Dagger Platform Technology, which is designed to minimize or potentially eliminate the need for standard lymphodepletion.
The amended ALPHA3 trial now proceeds as a randomized study with two arms, comparing cema-cel after standard FC lymphodepletion to observation, the current standard of care. Statistical design of the trial and the prespecified study conduct remain the same.
The next milestone will be the futility analysis comparing MRD conversion, which is expected to occur in the first half of 2026.
ALLO Price Action: Allogene stock is down 14.63% at $1.05 at publication on Friday.
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