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

NCT06500273 | Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: ALLO-501A-202
• Study Type: interventional
• Target: 250
• Locations: 2 countries
• Sites: 64

Brief 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.

Conditions

Large B-cell Lymphoma

Keywords

Diffuse large B-cell lymphoma; DLBCL; Primary mediastinal B-cell lymphoma; LBCL; High grade B-cell lymphoma; HGBCL; Double-hit lymphoma; High-risk lymphoma; Minimal Residual Disease; MRD; CAR T; Allogeneic CAR T; CD19; cema-cel; cemacabtagene ansegedleucel; PMBCL; Consolidation; First-line; Front-line; Frontline; PhasED-Seq™; CLARITY™; AlloCAR T™

Outcome Measures

Primary Outcomes (1)

• Event-free survival per independent review committee assessment

  Up to 60 months

Secondary Outcomes (5)

• Progression-free survival per independent review committee assessment

  Up to 60 months

• Overall survival

  Up to 60 months

• Incidence and severity of adverse events and their relationship to cemacabtagene ansegedleucel and ALLO-647

  Up to 60 months

• Incidence and severity of laboratory toxicities related to cemacabtagene ansegedleucel and ALLO-647

  Up to 60 months

• Minimal residual disease clearance

  Up to 60 months

Study Arms (2)

cemacabtagene ansegedleucel

EXPERIMENTAL

Participants receive cemacabtagene ansegedleucel following lymphodepletion regimen comprised of fludarabine and cyclophosphamide.

Genetic: cemacabtagene ansegedleucel; Drug: Fludarabine; Drug: Cyclophosphamide; Device: Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™

Observation

OTHER

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™

Interventions

Fludarabine DRUG

Chemotherapy for lymphodepletion

Also known as: Fludara®

cemacabtagene ansegedleucel

Cyclophosphamide DRUG

Chemotherapy for lymphodepletion

Also known as: Cytoxan®

cemacabtagene ansegedleucel

cemacabtagene ansegedleucel GENETIC

An allogeneic CAR T cell therapy targeting CD19

Also known as: cema-cel

cemacabtagene ansegedleucel

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

A diagnostic test intended to identify patients with minimal residual disease at the end of first line treatment for LBCL.

Also known as: Foresight Lymphoma MRD Therapy Selection Test

Observation; cemacabtagene ansegedleucel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Participant achieved CR, or PR suitable for observation, at the end of first line therapy based on PET/CT evaluation
• Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™, is positive.
• Adult participants ≥18 years of age.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
• Adequate hematological, renal, hepatic, pulmonary, and cardiac function
• Non-hematologic toxicities related to prior therapy must be recovered to baseline or grade ≤1.

You may not qualify if:

• 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.
• Prior treatment with anti-CD19 targeted therapies.
• Anti-cancer treatment, including radiation, after end of treatment PET/CT and/or MRD testing is performed.
• Active and clinically significant autoimmune disease.
• Active systemic bacterial, fungal, or viral infections requiring systemic treatment.
• History of another primary malignancy or bone marrow disorder (e.g., myelofibrosis, smoldering multiple myeloma) within 3 years prior to enrollment.

Sponsors & Collaborators

• Allogene Therapeutics: lead
• Foresight Diagnostics, Inc.: collaborator

Study Sites (64)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

RECRUITING

Genesis Cancer and Blood Institute

Hot Springs, Arkansas, 71913, United States

RECRUITING

Alta Bates Summit Medical Center

Berkeley, California, 94704, United States

RECRUITING

City of Hope

Duarte, California, 91010, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

University of California, Davis Comprehensive Cancer Center

Sacramento, California, 91817, United States

RECRUITING

University of California, San Diego

San Diego, California, 92037, United States

RECRUITING

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Rocky Mountain Cancer Centers

Denver, Colorado, 80218, United States

RECRUITING

Medical Oncology Hematology Consultants

Newark, Delaware, 19713, United States

RECRUITING

MedStar Georgetown University Hospital

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

RECRUITING

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, 33176, United States

RECRUITING

Advent Health Cancer Institute

Orlando, Florida, 32804, United States

RECRUITING

Orlando Health Cancer Institute

Orlando, Florida, 32806, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Augusta University Georgia Cancer Center

Augusta, Georgia, 30912, United States

RECRUITING

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

IU Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

Indiana Blood and Marrow Transplantation

Indianapolis, Indiana, 46237, United States

RECRUITING

The University of Kansas Hospital

Kansas City, Kansas, 66205, United States

ACTIVE NOT RECRUITING

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

RECRUITING

University of Louisville Health Brown Cancer Center

Louisville, Kentucky, 40202, United States

RECRUITING

Norton Cancer Institute

Louisville, Kentucky, 40207, United States

RECRUITING

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201, United States

RECRUITING

The Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

University of Missouri - Ellis Fischel Cancer Center

Columbia, Missouri, 65212, United States

RECRUITING

MidAmerica Cancer Care

Kansas City, Missouri, 64132, United States

RECRUITING

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, 63110, United States

RECRUITING

Astera Cancer Care

East Brunswick, New Jersey, 08816, United States

RECRUITING

John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

RECRUITING

Columbia University Irving Medical Center and New York-Presbyterian Hospital

New York, New York, 10032, United States

RECRUITING

University of Rochester Medical Center

Rochester, New York, 14642, United States

RECRUITING

Novant Health Cancer Institute- Hematology

Charlotte, North Carolina, 28204, United States

RECRUITING

Duke Blood Cancer Center

Durham, North Carolina, 27705, United States

RECRUITING

Oncology Hematology Care - Kenwood

Cincinnati, Ohio, 45236, United States

RECRUITING

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Oncology Associates of Oregon

Eugene, Oregon, 97401, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Texas Oncology - Central South

Austin, Texas, 78705, United States

RECRUITING

Texas Oncology - Dallas Fort Worth

Dallas, Texas, 75246, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Texas Transplant Institute

San Antonio, Texas, 78229, United States

RECRUITING

Texas Oncology - Tyler

Tyler, Texas, 75702, United States

RECRUITING

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Intermountain Health LDS Hospital

Salt Lake City, Utah, 84142, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

RECRUITING

Virginia Oncology Associates - Norfolk

Norfolk, Virginia, 23502, United States

RECRUITING

Swedish Cancer Institute

Seattle, Washington, 98104, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

Arthur JE Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 5G2, Canada

RECRUITING

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

RECRUITING

Princess Margaret Cancer Centre - University Health Network

Toronto, Ontario, M5G 1Z5, Canada

RECRUITING

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

RECRUITING

CHUM - University of Montreal Hospital Centre

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

Hopital de'L'Enfant-Jesus

Québec, Quebec, G1R 2J6, Canada

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Neoplasm, Residual

Interventions

fludarabine; fludarabine phosphate; Cyclophosphamide

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Allogene Study Director

  Allogene Therapeutics, Inc.

  STUDY DIRECTOR

Central Study Contacts

Allogene Therapeutics, Inc

CONTACT

+1 415-604-5696; clinicaltrials@allogene.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 15, 2024
• Study Start: June 18, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2032
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (58); CA (6)