On April 13, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported Allogene Therapeutics’ (NASDAQ: ALLO) interim futility analysis from its registrational ALPHA3 trial for cemacabtagene ansegedleucel (cema-cel), an investigational allogeneic anti-CD19 CAR T therapy, in first-line (1L) consolidation large B-cell lymphoma (LBCL).
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The ALPHA3 trial is enrolling patients with LBCL who test positive for molecular residual disease (MRD) following 1L therapy. These patients are then randomized either to cema-cel, an investigational allogeneic anti-CD19 CAR T therapy developed by Allogene, or observation. The interim analysis showed that 58.3% of MRD-positive patients treated with cema-cel achieved MRD clearance. In addition, at the Day-45 MRD assessment, plasma ctDNA levels decreased from baseline by a median of 97.7% in the cema-cel arm compared to a 26.6% median increase in the observation arm, suggesting molecular disease progression due to lack of intervention. These findings provide early evidence that cema-cel may help prevent or delay clinical relapse for LBCL patients with MRD.
While standard 1L chemoimmunotherapy (e.g., R-CHOP) is effective for most patients in achieving remission, approximately 30% will experience relapse. MRD assessment can identify such relapse before it shows up on imaging.1
ALPHA3 is the first MRD-guided randomized controlled trial in LBCL. The study is designed to assess whether treatment with an allogenic CAR T product can eliminate residual disease and potentially prevent recurrence. The study identifies high-risk patients using Natera’s CLARITYTM MRD assay, which leverages Natera’s patented phased variant MRD technology.
The interim analysis evaluated MRD clearance following treatment at a protocol-defined data cutoff. This represents another critical application for Natera’s MRD technology, providing a meaningful interim endpoint for assessing drug efficacy.
"MRD status following frontline therapy has emerged as one of the strongest predictors of relapse in LBCL, and the ALPHA3 study and cema-cel could be transformative for patients with lymphoma," said David Kurtz, M.D., Ph.D., senior vice president & chief scientific officer, Hematology Franchise at Natera. "Pairing our ultra-sensitive phased variant MRD technology with cema-cel, pending the outcome of ALPHA 3 study, creates an actionable solution for patients who test positive for MRD at the end of 1L treatment."
Allogene will host a conference call and webcast today at 5:30 a.m. PT / 8:30 a.m. ET to discuss the interim futility analysis. The webcast will be made available at www.allogene.com under the Investors tab in the News and Events section.
(Press release, Natera, APR 13, 2026, View Source [SID1234664337])