Recruiting

Phase 2

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

Sponsor:

Allogene Therapeutics

Code:

NCT06500273

Conditions

Large B-cell Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

cemacabtagene ansegedleucel

Fludarabine

Cyclophosphamide

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

Study Details

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

Study ID

NCT06500273

Start date

Jun 18, 2024

Status verified date

Aug, 2026

Completion date

Dec, 2032

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: cemacabtagene ansegedleucel

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

other: Observation

Participants do not receive any study treatments. They are observed as per the current standard of care.

Interventions

cemacabtagene ansegedleucel

An allogeneic CAR T cell therapy targeting CD19

Fludarabine

Chemotherapy for lymphodepletion

Cyclophosphamide

Chemotherapy for lymphodepletion

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.

Primary outcome measure

Event-free survival per independent review committee assessment [ Time Frame: Up to 60 months ]

Central Contacts and Locations

Central contacts

Allogene Therapeutics, Inc

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

Locations

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

Principal Investigator:

Matthew Ulrickson, MD

Genesis Cancer and Blood Institute

Recruiting

Hot Springs, Arkansas, United States, 71913

Principal Investigator:

Stephen Divers, MD

Alta Bates Summit Medical Center

Recruiting

Berkeley, California, United States, 94704

Principal Investigator:

Oleg Krijanovski, MD

City of Hope

Recruiting

Duarte, California, United States, 91010

Principal Investigator:

Geoffrey Shouse, MD

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Principal Investigator:

Akil Merchant, MD

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Principal Investigator:

Sven DeVos, MD

University of California, Davis Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95817

Principal Investigator:

Naseem Esteghamat, MD

University of California, San Diego

Recruiting

San Diego, California, United States, 92037

Principal Investigator:

Ayad Hamdan, MD

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Principal Investigator:

Michael Spinner, MD

Rocky Mountain Cancer Centers

Recruiting

Lone Tree, Colorado, United States, 80124

Principal Investigator:

John Burke, MD

Medical Oncology Hematology Consultants

Recruiting

Newark, Delaware, United States, 19713

Principal Investigator:

Jamal Misleh, MD

MedStar Georgetown University Hospital

Recruiting

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

Principal Investigator:

Kieron Dunleavy, MD

Miami Cancer Institute at Baptist Health, Inc.

Recruiting

Miami, Florida, United States, 33176

Principal Investigator:

Yuliya Linhares, MD

Advent Health Cancer Institute

Recruiting

Orlando, Florida, United States, 32804

Principal Investigator:

Rushang Patel, MD

Orlando Health Cancer Institute

Recruiting

Orlando, Florida, United States, 32806

Principal Investigator:

Abhishek Chilkulwar, MD

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Principal Investigator:

Frederick Locke, MD

Augusta University Georgia Cancer Center

Recruiting

Augusta, Georgia, United States, 30912

Principal Investigator:

Locke Bryan, MD

Northwestern University - Feinberg School of Medicine

Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator:

Reem Karmali, MD

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Principal Investigator:

Sunita Nathan, MD

Fort Wayne Medical Oncology and Hematology

Recruiting

Fort Wayne, Indiana, United States, 46804

Principal Investigator:

Sunil Babu, MD

IU Simon Comprehensive Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

Principal Investigator:

Varun Mittal, MD

Indiana Blood and Marrow Transplantation

Recruiting

Indianapolis, Indiana, United States, 46237

Principal Investigator:

Anand Tandra, MD

University of Kentucky Medical Center

Recruiting

Lexington, Kentucky, United States, 40536

Principal Investigator:

Chaitanya Iragavarapu, MD

University of Louisville Health Brown Cancer Center

Recruiting

Louisville, Kentucky, United States, 40202

Principal Investigator:

Hassaan Yasin, MD

Norton Cancer Institute

Recruiting

Louisville, Kentucky, United States, 40207

Principal Investigator:

Don Stevens, MD

University of Maryland Greenebaum Comprehensive Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

Principal Investigator:

Jean Yared, MD

The Center for Cancer and Blood Disorders

Recruiting

Bethesda, Maryland, United States, 20817

Principal Investigator:

Ralph Boccia, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator:

Jeremy Abramson, MD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Principal Investigator:

Michael Leukam, MD

University of Minnesota Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55455

Principal Investigator:

Veronica Bachanova, MD

University of Missouri - Ellis Fischel Cancer Center

Recruiting

Columbia, Missouri, United States, 65212

Principal Investigator:

Gerhard Hildebrandt, MD

MidAmerica Cancer Care

Recruiting

Kansas City, Missouri, United States, 64132

Principal Investigator:

Jaswinder Singh, MD

Washington University School of Medicine - Siteman Cancer Center

Recruiting

St Louis, Missouri, United States, 63110

Principal Investigator:

Nancy Bartlett, MD

Astera Cancer Care

Recruiting

East Brunswick, New Jersey, United States, 08816

Principal Investigator:

Edward Licitra, MD

John Theurer Cancer Center

Recruiting

Hackensack, New Jersey, United States, 07601

Principal Investigator:

Lori Leslie, MD

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08901

Principal Investigator:

Matthew Matasar, MD

Columbia University Irving Medical Center and New York-Presbyterian Hospital

Recruiting

New York, New York, United States, 10032

Principal Investigator:

Ran Reshef, MD

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Principal Investigator:

Patrick Reagan, MD

Novant Health Cancer Institute- Hematology

Recruiting

Charlotte, North Carolina, United States, 28204

Principal Investigator:

Alan Skarbnik, MD

Duke Blood Cancer Center

Recruiting

Durham, North Carolina, United States, 27705

Principal Investigator:

Mitchell Horwitz, MD

Oncology Hematology Care - Kenwood

Recruiting

Cincinnati, Ohio, United States, 45236

Principal Investigator:

Ahmed Galal, MD

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45267

Principal Investigator:

Tahir Latif, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Principal Investigator:

Paolo Caimi, MD

Oncology Associates of Oregon

Recruiting

Eugene, Oregon, United States, 97401

Principal Investigator:

Jeff Sharman, MD

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Principal Investigator:

Richard Maziarz, MD

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Principal Investigator:

Rashmi Khanal, MD

West Penn Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Principal Investigator:

Prerna Mewawalla, MD

Avera Cancer Institute

Recruiting

Sioux Falls, South Dakota, United States, 57105

Principal Investigator:

Waqas Jehangir, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Principal Investigator:

Andrew Jallouk, MD

Texas Oncology - Central South

Recruiting

Austin, Texas, United States, 78705

Principal Investigator:

Jason Melear, MD

Texas Oncology - Dallas Fort Worth

Recruiting

Dallas, Texas, United States, 75203

Principal Investigator:

Houston Holmes, MD

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Jason Westin, MD

Texas Transplant Institute

Recruiting

San Antonio, Texas, United States, 78229

Principal Investigator:

Nosha Farhadfar, MD

Texas Oncology - Tyler

Recruiting

Tyler, Texas, United States, 75702

Principal Investigator:

Habte Yimer, MD

Huntsman Cancer Institute, University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Principal Investigator:

Lindsey Fitzgerald, MD

Intermountain Health LDS Hospital

Recruiting

Salt Lake City, Utah, United States, 84142

Principal Investigator:

Bradley Hunter, MD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Principal Investigator:

Indumathy Varadarajan, MD

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Principal Investigator:

Mitul Gandhi, MD

Virginia Oncology Associates - Norfolk

Recruiting

Norfolk, Virginia, United States, 23502

Principal Investigator:

Gary Simmons, MD

Swedish Cancer Institute

Recruiting

Seattle, Washington, United States, 98104

Principal Investigator:

Matthew Schwede, MD

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Principal Investigator:

Ryan Lynch, MD

Arthur JE Child Comprehensive Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 5G2

Principal Investigator:

Mona Shafey, MD

Queen Elizabeth II Health Sciences Centre

Recruiting

Halifax, Nova Scotia, Canada, B3H 2Y9

Principal Investigator:

Mahmoud Elsawy, MD

Princess Margaret Cancer Centre - University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 1Z5

Principal Investigator:

John Kuruvilla, MD

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

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Principal Investigator:

Sandra Cohen, MD

CHUM - University of Montreal Hospital Centre

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Principal Investigator:

Xavier Deschenes-Simard, MD

Hopital de'L'Enfant-Jesus

Recruiting

Québec, Quebec, Canada, G1R 2J6

Principal Investigator:

Christopher Lemieux, MD

More Information

Sponsor

Allogene Therapeutics

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

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™

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Allogene Therapeutics on 2026-08-31.