Actively Recruiting
Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
Led by Allogene Therapeutics · Updated on 2026-05-06
250
Participants Needed
64
Research Sites
441 weeks
Total Duration
On this page
Sponsors
A
Allogene Therapeutics
Lead Sponsor
F
Foresight Diagnostics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with large B-cell lymphoma (LBCL) per WHO 2017 including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, or primary mediastinal B-cell lymphoma confirmed by pathology
- Completed a full course of standard first line therapy (e.g., R-CHOP, dose-adjusted EPOCH-R, Pola-R-CHP) with no additional therapies
- Achieved complete response (CR) or partial response (PR) suitable for observation at end of first line therapy based on PET/CT
- Positive minimal residual disease (MRD) by Foresight CLARITY IUO MRD test powered by PhasED-Seq
- Adults aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate blood, kidney, liver, lung, and heart function
- Non-hematologic side effects from prior therapy recovered to baseline or are grade 1 or lower
You will not qualify if you...
- History of LBCL with central nervous system involvement, transformation from other malignancies, or T-cell/histiocyte rich LBCL
- Prior treatment with anti-CD19 targeted therapies
- Received any anti-cancer treatment, including radiation, after PET/CT and/or MRD testing confirming response
- Active and clinically significant autoimmune disease
- Active systemic bacterial, fungal, or viral infections requiring treatment
- History of another primary cancer or bone marrow disorder within 3 years before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 64 locations
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
Genesis Cancer and Blood Institute
Hot Springs, Arkansas, United States, 71913
Actively Recruiting
3
Alta Bates Summit Medical Center
Berkeley, California, United States, 94704
Actively Recruiting
4
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
5
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
6
University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
7
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States, 91817
Actively Recruiting
8
University of California, San Diego
San Diego, California, United States, 92037
Actively Recruiting
9
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
10
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
Actively Recruiting
11
Medical Oncology Hematology Consultants
Newark, Delaware, United States, 19713
Actively Recruiting
12
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
13
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States, 33176
Actively Recruiting
14
Advent Health Cancer Institute
Orlando, Florida, United States, 32804
Actively Recruiting
15
Orlando Health Cancer Institute
Orlando, Florida, United States, 32806
Actively Recruiting
16
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
17
Augusta University Georgia Cancer Center
Augusta, Georgia, United States, 30912
Actively Recruiting
18
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
19
IU Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
20
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, United States, 46237
Actively Recruiting
21
The University of Kansas Hospital
Kansas City, Kansas, United States, 66205
Active, Not Recruiting
22
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
23
University of Louisville Health Brown Cancer Center
Louisville, Kentucky, United States, 40202
Actively Recruiting
24
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
Actively Recruiting
25
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
26
The Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
Actively Recruiting
27
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
28
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
29
University of Missouri - Ellis Fischel Cancer Center
Columbia, Missouri, United States, 65212
Actively Recruiting
30
MidAmerica Cancer Care
Kansas City, Missouri, United States, 64132
Actively Recruiting
31
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States, 63110
Actively Recruiting
32
Astera Cancer Care
East Brunswick, New Jersey, United States, 08816
Actively Recruiting
33
John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
34
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
35
Columbia University Irving Medical Center and New York-Presbyterian Hospital
New York, New York, United States, 10032
Actively Recruiting
36
University of Rochester Medical Center
Rochester, New York, United States, 14642
Actively Recruiting
37
Novant Health Cancer Institute- Hematology
Charlotte, North Carolina, United States, 28204
Actively Recruiting
38
Duke Blood Cancer Center
Durham, North Carolina, United States, 27705
Actively Recruiting
39
Oncology Hematology Care - Kenwood
Cincinnati, Ohio, United States, 45236
Actively Recruiting
40
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
Actively Recruiting
41
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
42
Oncology Associates of Oregon
Eugene, Oregon, United States, 97401
Actively Recruiting
43
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
44
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
45
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
46
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
47
Texas Oncology - Central South
Austin, Texas, United States, 78705
Actively Recruiting
48
Texas Oncology - Dallas Fort Worth
Dallas, Texas, United States, 75246
Actively Recruiting
49
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
50
Texas Transplant Institute
San Antonio, Texas, United States, 78229
Actively Recruiting
51
Texas Oncology - Tyler
Tyler, Texas, United States, 75702
Actively Recruiting
52
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
53
Intermountain Health LDS Hospital
Salt Lake City, Utah, United States, 84142
Actively Recruiting
54
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
55
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
56
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, United States, 23502
Actively Recruiting
57
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Actively Recruiting
58
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
59
Arthur JE Child Comprehensive Cancer Centre
Calgary, Alberta, Canada, T2N 5G2
Actively Recruiting
60
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 2Y9
Actively Recruiting
61
Princess Margaret Cancer Centre - University Health Network
Toronto, Ontario, Canada, M5G 1Z5
Actively Recruiting
62
Centre Integre Universitaire de Sante et Services Sociaux de L'Est de I'lle de Montreal / installation Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
Actively Recruiting
63
CHUM - University of Montreal Hospital Centre
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
64
Hopital de'L'Enfant-Jesus
Québec, Quebec, Canada, G1R 2J6
Actively Recruiting
Research Team
A
Allogene Therapeutics, Inc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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