NCT06500273

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Allogene Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Large B-cell Lymphoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-18
• Primary completion: 2027-12-01
• Completion: 2032-12-01
• First posted: 2024-07-15
• Last updated: 2026-03-18

Locations

61 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study
• FDA-regulated device study