RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Allogene Therapeutics • ClinicalTrials.gov ID: NCT06500273

Registry updated: 2026-10-02

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Description

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.

Interventions

cemacabtagene ansegedleucel (Genetic)
An allogeneic CAR T cell therapy targeting CD19
Fludarabine (Drug)
Chemotherapy for lymphodepletion
Cyclophosphamide (Drug)
Chemotherapy for lymphodepletion
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.

Eligibility criteria

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.

Conditions

Large B-cell Lymphoma

Locations

Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
Genesis Cancer and Blood Institute — Hot Springs, Arkansas, United States
Alta Bates Summit Medical Center — Berkeley, California, United States
City of Hope — Duarte, California, United States
Cedars-Sinai Medical Center — Los Angeles, California, United States
University of California, Los Angeles — Los Angeles, California, United States
University of California, Davis Comprehensive Cancer Center — Sacramento, California, United States
University of California, San Diego — San Diego, California, United States
University of California, San Francisco — San Francisco, California, United States
Rocky Mountain Cancer Centers — Lone Tree, Colorado, United States
Medical Oncology Hematology Consultants — Newark, Delaware, United States
MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
Miami Cancer Institute at Baptist Health, Inc. — Miami, Florida, United States
Advent Health Cancer Institute — Orlando, Florida, United States
Orlando Health Cancer Institute — Orlando, Florida, United States
Moffitt Cancer Center — Tampa, Florida, United States
Augusta University Georgia Cancer Center — Augusta, Georgia, United States
Northwestern University - Feinberg School of Medicine — Chicago, Illinois, United States
Rush University Medical Center — Chicago, Illinois, United States
Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana, United States
IU Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States
Indiana Blood and Marrow Transplantation — Indianapolis, Indiana, United States
The University of Kansas Hospital — Kansas City, Kansas, United States
University of Kentucky Medical Center — Lexington, Kentucky, United States
University of Louisville Health Brown Cancer Center — Louisville, Kentucky, United States
Norton Cancer Institute — Louisville, Kentucky, United States
University of Maryland Greenebaum Comprehensive Cancer Center — Baltimore, Maryland, United States
The Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
University of Minnesota Medical Center — Minneapolis, Minnesota, United States
University of Missouri - Ellis Fischel Cancer Center — Columbia, Missouri, United States
MidAmerica Cancer Care — Kansas City, Missouri, United States
Oncology Hematology Associates — Springfield, Missouri, United States
Washington University School of Medicine - Siteman Cancer Center — St Louis, Missouri, United States
Astera Cancer Care — East Brunswick, New Jersey, United States
John Theurer Cancer Center — Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
Columbia University Irving Medical Center and New York-Presbyterian Hospital — New York, New York, United States
University of Rochester Medical Center — Rochester, New York, United States
Novant Health Cancer Institute- Hematology — Charlotte, North Carolina, United States
Duke Blood Cancer Center — Durham, North Carolina, United States
Oncology Hematology Care - Kenwood — Cincinnati, Ohio, United States
University of Cincinnati Medical Center — Cincinnati, Ohio, United States
Cleveland Clinic — Cleveland, Ohio, United States
Oncology Associates of Oregon — Eugene, Oregon, United States
Oregon Health and Science University — Portland, Oregon, United States
Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
West Penn Hospital — Pittsburgh, Pennsylvania, United States
Avera Cancer Institute — Sioux Falls, South Dakota, United States
Vanderbilt University Medical Center — Nashville, Tennessee, United States
Texas Oncology - Central South — Austin, Texas, United States
Texas Oncology - Dallas Fort Worth — Dallas, Texas, United States
MD Anderson Cancer Center — Houston, Texas, United States
Texas Transplant Institute — San Antonio, Texas, United States
Texas Oncology - Tyler — Tyler, Texas, United States
Huntsman Cancer Institute, University of Utah — Salt Lake City, Utah, United States
Intermountain Health LDS Hospital — Salt Lake City, Utah, United States
University of Virginia — Charlottesville, Virginia, United States
Virginia Cancer Specialists — Fairfax, Virginia, United States
Virginia Oncology Associates - Norfolk — Norfolk, Virginia, United States
Swedish Cancer Institute — Seattle, Washington, United States
Fred Hutchinson Cancer Center — Seattle, Washington, United States
Calvary Mater Newcastle — Waratah, New South Wales, Australia
Icon Cancer Centre Wesley — Auchenflower, Queensland, Australia
Royal Hobart Hospital — Hobart, Tasmania, Australia
Monash Health — Clayton, Victoria, Australia
St. Vincent's Hospital Melbourne — Fitzroy, Victoria, Australia
Austin Health — Heidelberg, Victoria, Australia
Hollywood Private Hospital — Nedlands, Western Australia, Australia
Arthur JE Child Comprehensive Cancer Centre — Calgary, Alberta, Canada
Queen Elizabeth II Health Sciences Centre — Halifax, Nova Scotia, Canada
Princess Margaret Cancer Centre - University Health Network — Toronto, Ontario, Canada
Centre Integre Universitaire de Sante et Services Sociaux de L'Est de I'lle de Montreal / installation Hopital Maisonneuve-Rosemont — Montreal, Quebec, Canada
CHUM - University of Montreal Hospital Centre — Montreal, Quebec, Canada
Hopital de'L'Enfant-Jesus — Québec, Quebec, Canada
Pusan National University Hospital — Seogu, Busan, South Korea
National Cancer Center — Goyang-si, Gyeonggi-do, South Korea
Ajou University Hospital — Suwon, Gyeonggi-do, South Korea
Chonnam National University, Hwasun Hospital — Hwasun, Jeollanam-do, South Korea
Seoul National University — Seoul, Seoul, South Korea
Severance Hospital, Yonsei University Health System — Seoul, Seoul, South Korea
Asan Medical Center — Seoul, Seoul, South Korea
Samsung Medical Center — Seoul, Seoul, South Korea
The Catholic University of Korea, Yeouido St. Mary's Hospital — Seoul, Seoul, South Korea

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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