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ASH 2025 | ALPHA3 study: first-line cema-cel consolidation for MRD-positive LBCL after standard therapy
John Burke, MD, Rocky Mountain Cancer Centers, Aurora, CO, shares an overview of the ongoing Phase II ALPHA3 study (NCT06500273) evaluating first-line consolidation with cemacabtagene ansegedleucel (cema-cel) in patients with large B-cell lymphoma (LBCL) who have detectable measurable residual disease (MRD) by circulating tumor DNA (ctDNA) after standard frontline treatment. The study aims to improve event-free survival (EFS) by intervening before clinical relapse. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
The ALPHA3 study, it was a trial in progress presentation, so a study that we’re all very excited about. You know, by way of background, there’s really two products being studied here. The first is an allogeneic CAR T-cell product called cema-cel. That is, it’s an off-the-shelf CAR T-cell product that has a knockout for CD52 in the T-cell receptor that targets CD19. The other product being tested is a circulating tumor DNA assay called PhaseSeq or Clarity...
The ALPHA3 study, it was a trial in progress presentation, so a study that we’re all very excited about. You know, by way of background, there’s really two products being studied here. The first is an allogeneic CAR T-cell product called cema-cel. That is, it’s an off-the-shelf CAR T-cell product that has a knockout for CD52 in the T-cell receptor that targets CD19. The other product being tested is a circulating tumor DNA assay called PhaseSeq or Clarity. And we’re studying these products in patients with diffuse large B-cell lymphoma. And so the way the study works is that patients are eligible if they have DLBCL that has gone into remission clinically by PET scan with conventional therapy. And they have to have sort of completed their conventional therapy, whether it’s R-CHOP or Pola or CHiP or whatever is given to try to cure their lymphoma. And they undergo at that time or soon after their end of treatment PET scan, measurement of ctDNA in the blood. And if the ctDNA indicates that they have undetectable minimal residual disease or MRD, then they don’t enroll on the treatment phase of the study and they’re considered to have an excellent prognosis because we know from prior studies that the large majority of the patients won’t relapse. On the other hand, if they have an MRD test that indicates circulating tumor DNA and therefore residual disease, the treatment that the patients receive. There’s two phases of the study, a part A and a part B, and we’re conducting part A right now. And that’s really to look at, to do some safety and biomarker-based futility analyses. Once that’s done, we’ll then enroll a larger part B of the study where the primary endpoint is event-free survival. Again, testing whether this treatment modality can improve event-free survival compared with the more conventional approach of waiting until patients relapse and then delivering an autologous CAR T-cell therapy or whatever salvage therapy happens to be available at that time point. So that’s the design of this ongoing study. It’s enrolling patients throughout different sites in the U.S. and Canada. And so that’s it.
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