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

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

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Genetic
  cemacabtagene ansegedleucel

  An allogeneic CAR T cell therapy targeting CD19

• Drug
  Fludarabine

  Chemotherapy for lymphodepletion

• Drug
  Cyclophosphamide

  Chemotherapy for lymphodepletion

• Device
  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.

Locations (64)