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

Last updated: March 16, 2026
Sponsor: Allogene Therapeutics
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma

Lymphoma, B-cell

Treatment

ALLO-647

Fludarabine

cemacabtagene ansegedleucel

Clinical Study ID

NCT06500273
ALLO-501A-202
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. LBCL per WHO 2017 including diffuse large B-cell lymphoma, high-grade B-celllymphoma, and primary mediastinal B-cell lymphoma histologically confirmed bypathology 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 havereceived additional lines of therapy.

  3. Participant achieved CR, or PR suitable for observation, at the end of first linetherapy 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 orgrade ≤1.

Exclusion

Key Exclusion Criteria:

  1. LBCL with history of central nervous system involvement, transformed from othermalignancy (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 MRDtesting 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

Total Participants: 250
Treatment Group(s): 5
Primary Treatment: ALLO-647
Phase: 2
Study Start date:
June 18, 2024
Estimated Completion Date:
December 31, 2032

Connect with a study center

  • Arthur JE Child Comprehensive Cancer Centre

    Calgary, Alberta T2N 5G2
    Canada

    Active - Recruiting

  • Arthur JE Child Comprehensive Cancer Centre

    Calgary 5913490, Alberta 5883102 T2N 5G2
    Canada

    Site Not Available

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Active - Recruiting

  • Queen Elizabeth II Health Sciences Centre

    Halifax 6324729, Nova Scotia 6091530 B3H 2Y9
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre - University Health Network

    Toronto, Ontario M5G 1Z5
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Centre - University Health Network

    Toronto 6167865, Ontario 6093943 M5G 1Z5
    Canada

    Site Not Available

  • CHUM - University of Montreal Hospital Centre

    Montreal, Quebec H2X 0A9
    Canada

    Active - Recruiting

  • Hopital de'L'Enfant-Jesus

    Québec, Quebec G1R 2J6
    Canada

    Active - Recruiting

  • Hopital de'L'Enfant-Jesus

    Québec 6325494, Quebec 6115047 G1R 2J6
    Canada

    Site Not Available

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona 85234
    United States

    Active - Recruiting

  • Banner MD Anderson Cancer Center

    Gilbert 5295903, Arizona 5551752 85234
    United States

    Site Not Available

  • Genesis Cancer and Blood Institute

    Hot Springs, Arkansas 71913
    United States

    Active - Recruiting

  • Genesis Cancer and Blood Institute

    Hot Springs 4115412, Arkansas 4099753 71913
    United States

    Site Not Available

  • Alta Bates Summit Medical Center

    Berkeley, California 94704
    United States

    Active - Recruiting

  • City of Hope

    Duarte, California 91010
    United States

    Active - Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • University of California, Los Angeles

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • University of California, Davis Comprehensive Cancer Center

    Sacramento, California 91817
    United States

    Active - Recruiting

  • University of California, San Diego

    San Diego, California 92037
    United States

    Active - Recruiting

  • University of California, San Francisco

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Alta Bates Summit Medical Center

    Berkeley 5327684, California 5332921 94704
    United States

    Site Not Available

  • City of Hope

    Duarte 5344147, California 5332921 91010
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles 5368361, California 5332921 90048
    United States

    Site Not Available

  • University of California, Los Angeles

    Los Angeles 5368361, California 5332921 90095
    United States

    Active - Recruiting

  • University of California, Davis Comprehensive Cancer Center

    Sacramento 5389489, California 5332921 91817
    United States

    Site Not Available

  • University of California, San Diego

    San Diego 5391811, California 5332921 92037
    United States

    Site Not Available

  • University of California, San Francisco

    San Francisco 5391959, California 5332921 94143
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Rocky Mountain Cancer Centers

    Denver 5419384, Colorado 5417618 80218
    United States

    Site Not Available

  • Medical Oncology Hematology Consultants

    Newark, Delaware 19713
    United States

    Active - Recruiting

  • Medical Oncology Hematology Consultants

    Newark 4143861, Delaware 4142224 19713
    United States

    Site Not Available

  • Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • MedStar Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia 20007
    United States

    Active - Recruiting

  • MedStar Georgetown University Hospital

    Washington D.C. 4140963, District of Columbia 4138106 20007
    United States

    Site Not Available

  • Miami Cancer Institute at Baptist Health, Inc.

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Advent Health Cancer Institute

    Orlando, Florida 32804
    United States

    Active - Recruiting

  • Orlando Health Cancer Institute

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Miami Cancer Institute at Baptist Health, Inc.

    Miami 4164138, Florida 4155751 33176
    United States

    Site Not Available

  • Advent Health Cancer Institute

    Orlando 4167147, Florida 4155751 32804
    United States

    Active - Recruiting

  • Orlando Health Cancer Institute

    Orlando 4167147, Florida 4155751 32806
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa 4174757, Florida 4155751 33612
    United States

    Site Not Available

  • Augusta University Georgia Cancer Center

    Augusta, Georgia 30912
    United States

    Active - Recruiting

  • Augusta University Georgia Cancer Center

    Augusta 4180531, Georgia 4197000 30912
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Rush University Medical Center

    Chicago 4887398, Illinois 4896861 60612
    United States

    Site Not Available

  • Indiana Blood and Marrow Transplantation

    Indianapolis, Indiana 46237
    United States

    Active - Recruiting

  • Indiana Blood and Marrow Transplantation

    Indianapolis 4259418, Indiana 4921868 46237
    United States

    Site Not Available

  • The University of Kansas Hospital

    Kansas City, Kansas 66205
    United States

    Site Not Available

  • The University of Kansas Hospital

    Kansas City 4273837, Kansas 4273857 66205
    United States

    Site Not Available

  • University of Kentucky Medical Center

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky 40207
    United States

    Active - Recruiting

  • University of Louisville Health Brown Cancer Center

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • University of Kentucky Medical Center

    Lexington 4297983, Kentucky 6254925 40536
    United States

    Site Not Available

  • Norton Cancer Institute

    Louisville 4299276, Kentucky 6254925 40207
    United States

    Active - Recruiting

  • University of Louisville Health Brown Cancer Center

    Louisville 4299276, Kentucky 6254925 40202
    United States

    Site Not Available

  • The Center for Cancer and Blood Disorders

    Bethesda, Maryland 20817
    United States

    Active - Recruiting

  • The Center for Cancer and Blood Disorders

    Bethesda 4348599, Maryland 4361885 20817
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Active - Recruiting

  • University of Missouri - Ellis Fischel Cancer Center

    Columbia, Missouri 65212
    United States

    Active - Recruiting

  • MidAmerica Cancer Care

    Kansas City, Missouri 64132
    United States

    Active - Recruiting

  • Washington University School of Medicine - Siteman Cancer Center

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine - Siteman Cancer Center

    St Louis, Missouri 63110
    United States

    Active - Recruiting

  • University of Missouri - Ellis Fischel Cancer Center

    Columbia 4381982, Missouri 4398678 65212
    United States

    Site Not Available

  • MidAmerica Cancer Care

    Kansas City 4393217, Missouri 4398678 64132
    United States

    Site Not Available

  • Washington University School of Medicine - Siteman Cancer Center

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Astera Cancer Care

    East Brunswick, New Jersey 08816
    United States

    Active - Recruiting

  • John Theurer Cancer Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • Astera Cancer Care

    East Brunswick 5097402, New Jersey 5101760 08816
    United States

    Site Not Available

  • John Theurer Cancer Center

    Hackensack 5098706, New Jersey 5101760 07601
    United States

    Site Not Available

  • Rutgers Cancer Institute of New Jersey

    New Brunswick 5101717, New Jersey 5101760 08901
    United States

    Site Not Available

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center and New York-Presbyterian Hospital

    New York, New York 10032
    United States

    Active - Recruiting

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center and New York-Presbyterian Hospital

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester 5134086, New York 5128638 14642
    United States

    Site Not Available

  • Novant Health Cancer Institute- Hematology

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Duke Blood Cancer Center

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • Novant Health Cancer Institute- Hematology

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Site Not Available

  • Duke Blood Cancer Center

    Durham 4464368, North Carolina 4482348 27705
    United States

    Site Not Available

  • Oncology Hematology Care - Kenwood

    Cincinnati, Ohio 45236
    United States

    Active - Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45267
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Oncology Hematology Care - Kenwood

    Cincinnati 4508722, Ohio 5165418 45236
    United States

    Site Not Available

  • University of Cincinnati Medical Center

    Cincinnati 4508722, Ohio 5165418 45267
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Site Not Available

  • Oncology Associates of Oregon

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Oncology Associates of Oregon

    Eugene 5725846, Oregon 5744337 97401
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland 5746545, Oregon 5744337 97239
    United States

    Site Not Available

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Active - Recruiting

  • Fox Chase Cancer Center

    Philadelphia 4560349, Pennsylvania 6254927 19111
    United States

    Site Not Available

  • Avera Cancer Institute

    Sioux Falls, South Dakota 57105
    United States

    Active - Recruiting

  • Avera Cancer Institute

    Sioux Falls 5231851, South Dakota 5769223 57105
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Site Not Available

  • Texas Oncology - Central South

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Texas Oncology - Dallas Fort Worth

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Texas Oncology - Longview Cancer Center

    Longview, Texas 75601
    United States

    Site Not Available

  • Texas Transplant Institute

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Texas Oncology - Tyler

    Tyler, Texas 75702
    United States

    Active - Recruiting

  • Texas Oncology - Central South

    Austin 4671654, Texas 4736286 78705
    United States

    Site Not Available

  • Texas Oncology - Dallas Fort Worth

    Dallas 4684888, Texas 4736286 75246
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Texas Transplant Institute

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • Texas Oncology - Tyler

    Tyler 4738214, Texas 4736286 75702
    United States

    Site Not Available

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • Intermountain Health LDS Hospital

    Salt Lake City, Utah 84142
    United States

    Active - Recruiting

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City 5780993, Utah 5549030 84112
    United States

    Site Not Available

  • Intermountain Health LDS Hospital

    Salt Lake City 5780993, Utah 5549030 84142
    United States

    Active - Recruiting

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Virginia Oncology Associates - Norfolk

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

  • University of Virginia

    Charlottesville 4752031, Virginia 6254928 22903
    United States

    Site Not Available

  • Virginia Cancer Specialists

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Site Not Available

  • Virginia Oncology Associates - Norfolk

    Norfolk 4776222, Virginia 6254928 23502
    United States

    Site Not Available

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Active - Recruiting

  • Swedish Cancer Institute

    Seattle, Washington 98104
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Center

    Seattle 5809844, Washington 5815135 98109
    United States

    Site Not Available

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