Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
NCT ID: NCT06500273
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
250 participants
INTERVENTIONAL
2024-06-18
2031-08-24
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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cemacabtagene ansegedleucel
Participants receive cemacabtagene ansegedleucel following lymphodepletion regimen comprised of fludarabine and cyclophosphamide.
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.
Observation
Participants do not receive any study treatments. They are observed as per the current standard of care.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Foresight Diagnostics, Inc.
UNKNOWN
Allogene Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Allogene Study Director
Role: STUDY_DIRECTOR
Allogene Therapeutics, Inc.
Locations
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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
Denver, 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
Rush University Medical Center
Chicago, Illinois, 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
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 Missouri - Ellis Fischel Cancer Center
Columbia, Missouri, United States
MidAmerica Cancer Care
Kansas City, 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
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
Fred Hutchinson Cancer Center
Seattle, Washington, United States
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
Hopital de'L'Enfant-Jesus
Québec, Quebec, Canada
Countries
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Central Contacts
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Other Identifiers
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ALLO-501A-202
Identifier Type: -
Identifier Source: org_study_id