Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
Recruiting now · Phase 2
Conditions studied: Large B-cell Lymphoma
In brief
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.
Key facts
- Study ID
- NCT06500273
- Run by
- Allogene Therapeutics
- People needed
- 250
- Starts
- 2024-06-18
- Expected to finish
- 2032-12-01
- Last updated by the study team
- 2026-07-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (enrolling)
- Alta Bates Summit Medical Center — Berkeley, California, United States (enrolling)
- City of Hope — Duarte, California, United States (enrolling)
- Genesis Cancer and Blood Institute — Hot Springs, Arkansas, United States (enrolling)
- University of California, Los Angeles — Los Angeles, California, United States (enrolling)
- University of California, Davis Comprehensive Cancer Center — Sacramento, California, United States (enrolling)
- University of California, San Diego — San Diego, California, United States (enrolling)
- University of California, San Francisco — San Francisco, California, United States (enrolling)
- Rocky Mountain Cancer Centers — Denver, Colorado, United States (enrolling)
- Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
- MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States (enrolling)
- Miami Cancer Institute at Baptist Health, Inc. — Miami, Florida, United States (enrolling)
- Advent Health Cancer Institute — Orlando, Florida, United States (enrolling)
- Orlando Health Cancer Institute — Orlando, Florida, United States (enrolling)
- Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
- Augusta University Georgia Cancer Center — Augusta, Georgia, United States (enrolling)
- Northwestern University - Feinberg School of Medicine — Chicago, Illinois, United States (enrolling)
- Rush University Medical Center — Chicago, Illinois, United States (enrolling)
- Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana, United States (enrolling)
- IU Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States (enrolling)
- Indiana Blood and Marrow Transplantation — Indianapolis, Indiana, United States (enrolling)
- Medical Oncology Hematology Consultants — Newark, Delaware, United States (enrolling)
- University of Kentucky Medical Center — Lexington, Kentucky, United States (enrolling)
- University of Louisville Health Brown Cancer Center — Louisville, Kentucky, United States (enrolling)
- Norton Cancer Institute — Louisville, Kentucky, United States (enrolling)
Full record on ClinicalTrials.gov
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