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NCT06500273PHASE2Recruiting

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

Allogene Therapeutics

Start Date

6/18/2024

Completion Date

12/1/2032

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

GENETIC

cemacabtagene ansegedleucel

DRUG

Fludarabine

DRUG

Cyclophosphamide

DEVICE

Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™

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Conditions

Large B-cell Lymphoma

Locations

Banner MD Anderson Cancer Center

Gilbert, Arizona 85234

United States

Genesis Cancer and Blood Institute

Hot Springs, Arkansas 71913

United States

Alta Bates Summit Medical Center

Berkeley, California 94704

United States

City of Hope

Duarte, California 91010

United States

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States

University of California, Los Angeles

Los Angeles, California 90095

United States

University of California, Davis Comprehensive Cancer Center

Sacramento, California 95817

United States

University of California, San Diego

San Diego, California 92037

United States

University of California, San Francisco

San Francisco, California 94143

United States

Rocky Mountain Cancer Centers

Denver, Colorado 80218

United States

Medical Oncology Hematology Consultants

Newark, Delaware 19713

United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia 20007

United States

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida 33176

United States

Advent Health Cancer Institute

Orlando, Florida 32804

United States

Orlando Health Cancer Institute

Orlando, Florida 32806

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Augusta University Georgia Cancer Center

Augusta, Georgia 30912

United States

Northwestern University - Feinberg School of Medicine

Chicago, Illinois 60611

United States

Rush University Medical Center

Chicago, Illinois 60612

United States

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana 46804

United States

IU Simon Comprehensive Cancer Center

Indianapolis, Indiana 46202

United States

Indiana Blood and Marrow Transplantation

Indianapolis, Indiana 46237

United States

The University of Kansas Hospital

Kansas City, Kansas 66205

United States

University of Kentucky Medical Center

Lexington, Kentucky 40536

United States

University of Louisville Health Brown Cancer Center

Louisville, Kentucky 40202

United States

Norton Cancer Institute

Louisville, Kentucky 40207

United States

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland 21201

United States

The Center for Cancer and Blood Disorders

Bethesda, Maryland 20817

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

University of Minnesota Medical Center

Minneapolis, Minnesota 55455

United States

University of Missouri - Ellis Fischel Cancer Center

Columbia, Missouri 65212

United States

MidAmerica Cancer Care

Kansas City, Missouri 64132

United States

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri 63110

United States

Astera Cancer Care

East Brunswick, New Jersey 08816

United States

John Theurer Cancer Center

Hackensack, New Jersey 07601

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey 08901

United States

Columbia University Irving Medical Center and New York-Presbyterian Hospital

New York, New York 10032

United States

University of Rochester Medical Center

Rochester, New York 14642

United States

Novant Health Cancer Institute- Hematology

Charlotte, North Carolina 28204

United States

Duke Blood Cancer Center

Durham, North Carolina 27705

United States

Oncology Hematology Care - Kenwood

Cincinnati, Ohio 45236

United States

University of Cincinnati Medical Center

Cincinnati, Ohio 45267

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Oncology Associates of Oregon

Eugene, Oregon 97401

United States

Oregon Health and Science University

Portland, Oregon 97239

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania 19111

United States

West Penn Hospital

Pittsburgh, Pennsylvania 15224

United States

Avera Cancer Institute

Sioux Falls, South Dakota 57105

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Texas Oncology - Central South

Austin, Texas 78705

United States

Texas Oncology - Dallas Fort Worth

Dallas, Texas 75246

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

Texas Transplant Institute

San Antonio, Texas 78229

United States

Texas Oncology - Tyler

Tyler, Texas 75702

United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah 84112

United States

Intermountain Health LDS Hospital

Salt Lake City, Utah 84142

United States

University of Virginia

Charlottesville, Virginia 22903

United States

Virginia Cancer Specialists

Fairfax, Virginia 22031

United States

Virginia Oncology Associates - Norfolk

Norfolk, Virginia 23502

United States

Swedish Cancer Institute

Seattle, Washington 98104

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States

Icon Cancer Centre Wesley

Auchenflower, Queensland 4066

Australia

Royal Hobart Hospital

Hobart, Tasmania 7000

Australia

Monash Health

Clayton, Victoria 3168

Australia

St. Vincent's Hospital Melbourne

Fitzroy, Victoria 3065

Australia

Austin Health

Heidelberg, Victoria 3084

Australia

Hollywood Private Hospital

Nedlands, Western Australia 6009

Australia

Arthur JE Child Comprehensive Cancer Centre

Calgary, Alberta T2N 5G2

Canada

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia B3H 2Y9

Canada

Princess Margaret Cancer Centre - University Health Network

Toronto, Ontario M5G 1Z5

Canada

Centre Integre Universitaire de Sante et Services Sociaux de L'Est de I'lle de Montreal / installation Hopital Maisonneuve-Rosemont

Montreal, Quebec H1T 2M4

Canada

CHUM - University of Montreal Hospital Centre

Montreal, Quebec H2X 0A9

Canada

Hopital de'L'Enfant-Jesus

Québec, Quebec G1R 2J6

Canada

Pusan National University Hospital

Seogu, Busan South Korea

South Korea

National Cancer Center

Goyang-si, Gyeonggi-do 10408

South Korea

Chonnam National University, Hwasun Hospital

Hwasun, Jeollanam-do 58128

South Korea

Seoul National University

Seoul, Seoul 03080

South Korea

Severance Hospital, Yonsei University Health System

Seoul, Seoul 03722

South Korea

Asan Medical Center

Seoul, Seoul 05505

South Korea

Samsung Medical Center

Seoul, Seoul 06351

South Korea

The Catholic University of Korea, Yeouido St. Mary's Hospital

Seoul, Seoul 07345

South Korea