Off-the-shelf CAR-T shows MRD clearance edge in Allogene's ALPHA3 data

Allogene Therapeutics reports early ALPHA3 data showing its off-the-shelf donor-derived CAR-T therapy cema-cel achieved a 41.6-percentage-point higher minimal residual disease (MRD) clearance at day 45 versus control (7/12 vs 2/12) in lymphoma patients with MRD after initial chemotherapy. Circulating tumor DNA dropped an average 97.7% in cema-cel-treated patients vs a 26.6% rise in control. No cases of cytokine release syndrome or neurotoxicity were observed, and most patients were treated as outpatients. The trial has enrolled just 24 of about 220 planned participants; enrollment is expected to finish by 2027, with event-free survival data due mid-2027 and mid-2028. If results confirm benefit, cema-cel could become the first donor-derived CAR-T therapy to seek FDA approval, potentially reshaping lymphoma treatment access.»