Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL

Condition(s) studied

Investigational drug(s) / intervention(s)

cemacabtagene ansegedleucel: An allogeneic CAR T cell therapy targeting CD19

Fludarabine: Chemotherapy for lymphodepletion

Cyclophosphamide: Chemotherapy for lymphodepletion

Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™: A diagnostic test intended to identify patients with minimal residual disease at the end of first line treatment for LBCL.

Study summary

This is a randomized, open-label study in adult patients who have completed standard first line therapy for large B-cell lymphoma (LBCL) and achieved a complete response or partial response suitable for observation, but who have minimal residual disease (MRD) as detected by the Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq™. The purpose of the trial is to assess the efficacy and safety of consolidation with cemacabtagene ansegedleucel (cema-cel), an allogeneic CD19 CAR T product, as compared to standard of care observation.

In this study, participants with MRD are randomized 1:1 to treatment with cema-cel or an observation arm. Treatment includes cema-cel following a lymphodepletion regimen of fludarabine and cyclophosphamide.

Prior to August 2025, participants may also have received an anti-CD52 monoclonal antibody, ALLO-647, as part of their lymphodepletion regimen.

Eligibility

Primary outcome measure(s)

• Event-free survival per independent review committee assessment — Up to 60 months

Trial sites (83)

+ 43 more sites — see the full list on the official registry below.

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