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

Last updated: April 28, 2025
Sponsor: Allogene Therapeutics
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma

Lymphoma, B-cell

Treatment

ALLO-647

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

Fludarabine

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.

The study is conducted in 2 consecutive parts that will be enrolled continuously. In Part A of the study, participants with MRD are randomized to one of two treatment arms or an observation arm. Treatment includes cema-cel following a lymphodepletion regimen of fludarabine and cyclophosphamide administered with or without the anti-CD52 monoclonal antibody, ALLO-647. Part A will culminate with the selection of the lymphodepletion regimen to advance to Part B. Part B will evaluate the selected lymphodepletion regimen followed by cema-cel as compared with observation.

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 (e.g., HIV).

  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:
August 24, 2031

Connect with a study center

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona 85234
    United States

    Active - Recruiting

  • 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

  • Rocky Mountain Cancer Centers

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Medical Oncology Hematology Consultants

    Newark, Delaware 19713
    United States

    Active - Recruiting

  • Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

  • MedStar Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

  • 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

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Augusta University Georgia Cancer Center

    Augusta, Georgia 30912
    United States

    Active - Recruiting

  • Indiana Blood and Marrow Transplantation

    Indianapolis, Indiana 46237
    United States

    Active - Recruiting

  • The University of Kansas Hospital

    Kansas City, Kansas 66205
    United States

    Active - Recruiting

  • 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

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Washington University School of Medicine - Siteman Cancer Center

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • 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

  • 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

  • Duke Blood Cancer Center

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • 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 Associates of Oregon

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • 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

  • 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

  • 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

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Active - Recruiting

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