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Phase 2Recruiting

Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL (ALPHA3)

A Randomized, Open-label Study Evaluating the Efficacy and Safety of Cemacabtagene Ansegedleucel in Participants With Minimal Residual Disease After Response to First Line Therapy for Large B-cell Lymphoma

Sponsor
Allogene Therapeutics (Industry)
Enrolment
250 planned
Conditions
Large B-cell Lymphoma
Interventions
cemacabtagene ansegedleucel; Fludarabine; Cyclophosphamide; Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™
Ages
adults, older adults
Registry
NCT06500273

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Event-free survival per independent review committee assessment

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Registered

  5. Started