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

Purpose

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.

Condition

  • Large B-cell Lymphoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
cemacabtagene ansegedleucel 		Participants receive cemacabtagene ansegedleucel following lymphodepletion regimen comprised of fludarabine and cyclophosphamide.
  • Genetic: cemacabtagene ansegedleucel
    An allogeneic CAR T cell therapy targeting CD19
    Other names:
    • cema-cel
  • Drug: Fludarabine
    Chemotherapy for lymphodepletion
    Other names:
    • Fludara®
  • Drug: Cyclophosphamide
    Chemotherapy for lymphodepletion
    Other names:
    • Cytoxan®
  • 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.
    Other names:
    • Foresight Lymphoma MRD Therapy Selection Test
Other
Observation 		Participants do not receive any study treatments. They are observed as per the current standard of care.
  • 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.
    Other names:
    • Foresight Lymphoma MRD Therapy Selection Test

Recruiting Locations

Banner MD Anderson Cancer Center
Gilbert, Arizona 85234

Genesis Cancer and Blood Institute
Hot Springs, Arkansas 71913

Alta Bates Summit Medical Center
Berkeley, California 94704

City of Hope
Duarte, California 91010

Cedars-Sinai Medical Center
Los Angeles, California 90048

University of California, Los Angeles
Los Angeles, California 90095

University of California, Davis Comprehensive Cancer Center
Sacramento, California 91817

University of California, San Diego
San Diego, California 92037

University of California, San Francisco
San Francisco, California 94143

Rocky Mountain Cancer Centers
Denver, Colorado 80218

Medical Oncology Hematology Consultants
Newark, Delaware 19713

MedStar Georgetown University Hospital
Washington D.C., District of Columbia 20007

Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida 33176

Advent Health Cancer Institute
Orlando, Florida 32804

Orlando Health Cancer Institute
Orlando, Florida 32806

Moffitt Cancer Center
Tampa, Florida 33612

Augusta University Georgia Cancer Center
Augusta, Georgia 30912

Northwestern University - Feinberg School of Medicine
Chicago, Illinois 60611

Rush University Medical Center
Chicago, Illinois 60612

IU Simon Comprehensive Cancer Center
Indianapolis, Indiana 46202

Indiana Blood and Marrow Transplantation
Indianapolis, Indiana 46237

University of Kentucky Medical Center
Lexington, Kentucky 40536

University of Louisville Health Brown Cancer Center
Louisville, Kentucky 40202

Norton Cancer Institute
Louisville, Kentucky 40207

University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland 21201

The Center for Cancer and Blood Disorders
Bethesda, Maryland 20817

Massachusetts General Hospital
Boston, Massachusetts 02114

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215

University of Missouri - Ellis Fischel Cancer Center
Columbia, Missouri 65212

MidAmerica Cancer Care
Kansas City, Missouri 64132

Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri 63110

Astera Cancer Care
East Brunswick, New Jersey 08816

John Theurer Cancer Center
Hackensack, New Jersey 07601

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901

Columbia University Irving Medical Center and New York-Presbyterian Hospital
New York, New York 10032

University of Rochester Medical Center
Rochester, New York 14642

Novant Health Cancer Institute- Hematology
Charlotte, North Carolina 28204

Duke Blood Cancer Center
Durham, North Carolina 27705

Oncology Hematology Care - Kenwood
Cincinnati, Ohio 45236

University of Cincinnati Medical Center
Cincinnati, Ohio 45267

Cleveland Clinic
Cleveland, Ohio 44195

Oncology Associates of Oregon
Eugene, Oregon 97401

Oregon Health and Science University
Portland, Oregon 97239

Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111

West Penn Hospital
Pittsburgh, Pennsylvania 15224

Avera Cancer Institute
Sioux Falls, South Dakota 57105

Vanderbilt University Medical Center
Nashville, Tennessee 37232

Texas Oncology - Central South
Austin, Texas 78705

Texas Oncology - Dallas Fort Worth
Dallas, Texas 75246

MD Anderson Cancer Center
Houston, Texas 77030

Texas Transplant Institute
San Antonio, Texas 78229

Texas Oncology - Tyler
Tyler, Texas 75702

Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah 84112

Intermountain Health LDS Hospital
Salt Lake City, Utah 84142

University of Virginia
Charlottesville, Virginia 22903

Virginia Cancer Specialists
Fairfax, Virginia 22031

Virginia Oncology Associates - Norfolk
Norfolk, Virginia 23502

Swedish Cancer Institute
Seattle, Washington 98104

Fred Hutchinson Cancer Center
Seattle, Washington 98109

More Details

Status
Recruiting
Sponsor
Allogene Therapeutics

Study Contact

Allogene Therapeutics, Inc
+1 415-604-5696
clinicaltrials@allogene.com