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

NCT06500273 · Allogene Therapeutics
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Official title
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
About this study
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 criteria
Key Inclusion Criteria: 1. LBCL per WHO 2017 including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and primary mediastinal B-cell lymphoma histologically confirmed by pathology report. 2. Participant has completed a full course of standard first line therapy (e.g., R-CHOP, dose-adjusted EPOCH-R, Pola-R-CHP) as intended. Participants cannot have received additional lines of therapy. 3. Participant achieved CR, or PR suitable for observation, at the end of first line therapy based on PET/CT evaluation 4. Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™, is positive. 5. Adult participants ≥18 years of age. 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 7. Adequate hematological, renal, hepatic, pulmonary, and cardiac function 8. Non-hematologic toxicities related to prior therapy must be recovered to baseline or grade ≤1. Key Exclusion Criteria: 1. LBCL with history of central nervous system involvement, transformed from other malignancy (e.g., transformed follicular lymphoma or marginal zone lymphoma, Richter's transformation), or T-cell/histiocyte rich LBCL. 2. Prior treatment with anti-CD19 targeted therapies. 3. Anti-cancer treatment, including radiation, after end of treatment PET/CT and/or MRD testing is performed. 4. Active and clinically significant autoimmune disease. 5. Active systemic bacterial, fungal, or viral infections requiring systemic treatment. 6. History of another primary malignancy or bone marrow disorder (e.g., myelofibrosis, smoldering multiple myeloma) within 3 years prior to enrollment.
Study design
Enrollment target: 250 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-06-18
Estimated completion: 2032-12
Last updated: 2026-03-18
Interventions
Genetic: cemacabtagene ansegedleucelDrug: FludarabineDrug: CyclophosphamideDevice: Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™
Primary outcomes
  • Event-free survival per independent review committee assessment (Up to 60 months)
Sponsor
Allogene Therapeutics · industry
With: Foresight Diagnostics, Inc.
Contacts & investigators
ContactAllogene Therapeutics, Inc · contact · clinicaltrials@allogene.com · +1 415-604-5696
InvestigatorAllogene Study Director · study_director, Allogene Therapeutics, Inc.
All locations (61)
Banner MD Anderson Cancer CenterRecruiting
Gilbert, Arizona, United States
Genesis Cancer and Blood InstituteRecruiting
Hot Springs, Arkansas, United States
Alta Bates Summit Medical CenterRecruiting
Berkeley, California, United States
City of HopeRecruiting
Duarte, California, United States
Cedars-Sinai Medical CenterRecruiting
Los Angeles, California, United States
University of California, Los AngelesRecruiting
Los Angeles, California, United States
University of California, Davis Comprehensive Cancer CenterRecruiting
Sacramento, California, United States
University of California, San DiegoRecruiting
San Diego, California, United States
University of California, San FranciscoRecruiting
San Francisco, California, United States
Rocky Mountain Cancer CentersRecruiting
Denver, Colorado, United States
Medical Oncology Hematology ConsultantsRecruiting
Newark, Delaware, United States
MedStar Georgetown University HospitalRecruiting
Washington D.C., District of Columbia, United States
Miami Cancer Institute at Baptist Health, Inc.Recruiting
Miami, Florida, United States
Advent Health Cancer InstituteRecruiting
Orlando, Florida, United States
Orlando Health Cancer InstituteRecruiting
Orlando, Florida, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Augusta University Georgia Cancer CenterRecruiting
Augusta, Georgia, United States
Rush University Medical CenterRecruiting
Chicago, Illinois, United States
Indiana Blood and Marrow TransplantationRecruiting
Indianapolis, Indiana, United States
The University of Kansas HospitalActive Not Recruiting
Kansas City, Kansas, United States
University of Kentucky Medical CenterRecruiting
Lexington, Kentucky, United States
University of Louisville Health Brown Cancer CenterRecruiting
Louisville, Kentucky, United States
Norton Cancer InstituteRecruiting
Louisville, Kentucky, United States
The Center for Cancer and Blood DisordersRecruiting
Bethesda, Maryland, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Beth Israel Deaconess Medical CenterRecruiting
Boston, Massachusetts, United States
University of Missouri - Ellis Fischel Cancer CenterRecruiting
Columbia, Missouri, United States
MidAmerica Cancer CareRecruiting
Kansas City, Missouri, United States
Washington University School of Medicine - Siteman Cancer CenterRecruiting
St Louis, Missouri, United States
Astera Cancer CareRecruiting
East Brunswick, New Jersey, United States
John Theurer Cancer CenterRecruiting
Hackensack, New Jersey, United States
Rutgers Cancer Institute of New JerseyRecruiting
New Brunswick, New Jersey, United States
Columbia University Irving Medical Center and New York-Presbyterian HospitalRecruiting
New York, New York, United States
University of Rochester Medical CenterRecruiting
Rochester, New York, United States
Novant Health Cancer Institute- HematologyRecruiting
Charlotte, North Carolina, United States
Duke Blood Cancer CenterRecruiting
Durham, North Carolina, United States
Oncology Hematology Care - KenwoodRecruiting
Cincinnati, Ohio, United States
University of Cincinnati Medical CenterRecruiting
Cincinnati, Ohio, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
Oncology Associates of OregonRecruiting
Eugene, Oregon, United States
Oregon Health and Science UniversityRecruiting
Portland, Oregon, United States
Fox Chase Cancer CenterRecruiting
Philadelphia, Pennsylvania, United States
Avera Cancer InstituteRecruiting
Sioux Falls, South Dakota, United States
Vanderbilt University Medical CenterRecruiting
Nashville, Tennessee, United States
Texas Oncology - Central SouthRecruiting
Austin, Texas, United States
Texas Oncology - Dallas Fort WorthRecruiting
Dallas, Texas, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Texas Transplant InstituteRecruiting
San Antonio, Texas, United States
Texas Oncology - TylerRecruiting
Tyler, Texas, United States
Huntsman Cancer Institute, University of UtahRecruiting
Salt Lake City, Utah, United States
Intermountain Health LDS HospitalRecruiting
Salt Lake City, Utah, United States
University of VirginiaRecruiting
Charlottesville, Virginia, United States
Virginia Cancer SpecialistsRecruiting
Fairfax, Virginia, United States
Virginia Oncology Associates - NorfolkRecruiting
Norfolk, Virginia, United States
Swedish Cancer InstituteRecruiting
Seattle, Washington, United States
Fred Hutchinson Cancer CenterRecruiting
Seattle, Washington, United States
Arthur JE Child Comprehensive Cancer CentreRecruiting
Calgary, Alberta, Canada
Queen Elizabeth II Health Sciences CentreRecruiting
Halifax, Nova Scotia, Canada
Princess Margaret Cancer Centre - University Health NetworkRecruiting
Toronto, Ontario, Canada
CHUM - University of Montreal Hospital CentreRecruiting
Montreal, Quebec, Canada
Hopital de'L'Enfant-JesusRecruiting
Québec, Quebec, Canada
Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL · TrialPath