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

NCT06500273 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-05-20

No results posted yet for this 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.

Conditions

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.

Sponsors & Collaborators

  • Foresight Diagnostics, Inc.

    collaborator UNKNOWN

  • Natera, Inc.

    collaborator INDUSTRY

  • Allogene Therapeutics

    lead INDUSTRY

Principal Investigators

  • Allogene Study Director · Allogene Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-18
Primary Completion
2027-12-31
Completion
2032-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Australia
  • Canada

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06500273 on ClinicalTrials.gov