What's Happening?
Allogene Therapeutics has decided to discontinue the use of its monoclonal antibody ALLO-647 in its Phase II ALPHA3 trial following a patient death. The trial was investigating cemacabtagene ansegedleucel, a CAR T therapy for large B-cell lymphoma. The death was attributed to liver failure caused by disseminated adenovirus infection in the setting of immune suppression linked to ALLO-647. Allogene will now proceed with fludarabine and cyclophosphamide as lymphodepletion treatments, excluding ALLO-647 from its pipeline.
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Why It's Important?
The decision to discontinue ALLO-647 highlights the challenges and risks associated with immunosuppressive therapies in clinical trials. The incident underscores the importance of safety in drug development, particularly in treatments involving immune suppression. Allogene's move to focus on alternative lymphodepletion regimens may lead to safer treatment protocols and potentially higher commercial uptake for cemacabtagene ansegedleucel if approved. The biotech industry must balance innovation with patient safety, ensuring rigorous evaluation of new therapies.
What's Next?
Allogene plans to conduct a futility analysis for the ALPHA3 trial in the first half of 2026. The company will continue to evaluate the efficacy and safety of its CAR T therapy using the revised lymphodepletion regimen. Stakeholders in the biotech industry may monitor the outcomes of the trial closely, as they could influence future approaches to immunosuppressive treatments. The incident may prompt increased scrutiny and regulatory oversight in clinical trials involving immune suppression.
