Allogene Therapeutics initiates Phase 2 cema-cel trial

Allogene Therapeutics announced the initiation of the pivotal Phase 2 ALPHA3 trial evaluating the use of cemacabtagene ansegedleucel as part of the first line treatment regimen for newly diagnosed LBCL patients who are likely to relapse after standard 1L treatment and need further therapy. The ALPHA3 trial will screen patients who are likely to relapse after 1L treatment for enrollment in the trial by using the Foresight CLARITY Investigational Use Only MRD test, powered by PhasED-Seq, which recently received Investigational Device Exemption approval from the U.S. Food and Drug Administration. Leveraging CLARITY’s ultra-sensitive MRD technology, cema-cel will be administered as a one-time infusion immediately upon detection of MRD at the completion of six cycles of R-CHOP or other standard 1L chemoimmunotherapy regimen. When given as a “7th cycle” of frontline treatment to eligible patients with MRD, consolidation treatment with cema-cel has the potential to meaningfully improve 1L cure rates in LBCL. “Following the FDA Advisory Committee’s recent recommendation to include MRD as an endpoint to accelerate clinical trials in multiple myeloma, the ALPHA3 trial is yet another step forward towards broader implementation of MRD detection in drug development and clinical decision making,” said Dr. Sandra Close, Chief Operating and Compliance Officer at Foresight Diagnostics. “We believe the Foresight CLARITY MRD platform has the performance to enable actionable treatment decisions at end of therapy when residual disease levels are challenging to detect using conventional methods.” The ALPHA3 trial will be conducted in a wide array of cancer treatment centers, including community cancer centers where most earlier line patients seek care. This randomized study will enroll approximately 240 patients and is designed to demonstrate a meaningful improvement in event free survival in patients treated with cema-cel relative to patients who receive the current standard of care. Efficacy analyses are expected to occur in 2026 and will include an interim EFS analysis monitored by the independent Data Safety Monitoring Board in 1H 2026 and the data readout of the primary EFS analysis in 2H 2026 with a potential biologics license application submission targeted for 2027.