Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL (ALPHA3)

June 1, 2026 updated by: Allogene Therapeutics

A Randomized, Open-label Study Evaluating the Efficacy and Safety of Cemacabtagene Ansegedleucel in Participants With Minimal Residual Disease After Response to First Line Therapy for Large B-cell Lymphoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Recruiting
        • Icon Cancer Centre Wesley
        • Principal Investigator:
          • Karthik Nath, MD
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Recruiting
        • Royal Hobart Hospital
        • Principal Investigator:
          • Anna Johnston, MD
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Health
        • Principal Investigator:
          • Danielle Oh, MD
      • Fitzroy, Victoria, Australia, 3065
        • Recruiting
        • St. Vincent's Hospital Melbourne
        • Principal Investigator:
          • Matthew Ku, MD
      • Heidelberg, Victoria, Australia, 3084
        • Recruiting
        • Austin Health
        • Principal Investigator:
          • Denise Lee, MD
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • Hollywood Private Hospital
        • Principal Investigator:
          • Chan Cheah, MD
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Recruiting
        • Arthur Je Child Comprehensive Cancer Centre
        • Principal Investigator:
          • Mona Shafey, MD
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Recruiting
        • Queen Elizabeth II Health Sciences Centre
        • Principal Investigator:
          • Mahmoud Elsawy, MD
    • Ontario
      • Toronto, Ontario, Canada, M5G 1Z5
        • Recruiting
        • Princess Margaret Cancer Centre - University Health Network
        • Principal Investigator:
          • John Kuruvilla, MD
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Recruiting
        • CHUM - University of Montreal Hospital Centre
        • Principal Investigator:
          • Xavier Deschenes-Simard, MD
      • Montreal, Quebec, Canada, H1T 2M4
        • Recruiting
        • Centre Integre Universitaire de Sante et Services Sociaux de L'Est de I'lle de Montreal / installation Hopital Maisonneuve-Rosemont
        • Principal Investigator:
          • Sandra Cohen, MD
      • Québec, Quebec, Canada, G1R 2J6
        • Recruiting
        • Hopital de'L'Enfant-Jesus
        • Principal Investigator:
          • Christopher Lemieux, MD
  • South Korea
    • Busan
      • Seogu, Busan, South Korea, South Korea
        • Recruiting
        • Pusan National University Hospital
        • Principal Investigator:
          • Shin Ho-jin, MD
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Recruiting
        • Banner MD Anderson Cancer Center
        • Principal Investigator:
          • Matthew Ulrickson, MD
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Recruiting
        • Genesis Cancer and Blood Institute
        • Principal Investigator:
          • Stephen Divers, MD
    • California
      • Berkeley, California, United States, 94704
        • Recruiting
        • Alta Bates Summit Medical Center
        • Principal Investigator:
          • Oleg Krijanovski, MD
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Principal Investigator:
          • Geoffrey Shouse, MD
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California, Los Angeles
        • Principal Investigator:
          • Sven DeVos, MD
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Principal Investigator:
          • Akil Merchant, MD
      • Sacramento, California, United States, 91817
        • Recruiting
        • University of California, Davis Comprehensive Cancer Center
        • Principal Investigator:
          • Naseem Esteghamat, MD
      • San Diego, California, United States, 92037
        • Recruiting
        • University of California, San Diego
        • Principal Investigator:
          • Ayad Hamdan, MD
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Principal Investigator:
          • Michael Spinner, MD
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Rocky Mountain Cancer Centers
        • Principal Investigator:
          • John Burke, MD
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Medical Oncology Hematology Consultants
        • Principal Investigator:
          • Jamal Misleh, MD
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Recruiting
        • MedStar Georgetown University Hospital
        • Principal Investigator:
          • Kieron Dunleavy, MD
    • Florida
      • Miami, Florida, United States, 33176
        • Recruiting
        • Miami Cancer Institute at Baptist Health, Inc.
        • Principal Investigator:
          • Yuliya Linhares, MD
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Cancer Institute
        • Principal Investigator:
          • Juan Varela, MD
      • Orlando, Florida, United States, 32804
        • Recruiting
        • Advent Health Cancer Institute
        • Principal Investigator:
          • Rushang Patel, MD
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Principal Investigator:
          • Frederick Locke, MD
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Augusta University Georgia Cancer Center
        • Principal Investigator:
          • Locke Bryan, MD
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Principal Investigator:
          • Sunita Nathan, MD
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University - Feinberg School of Medicine
        • Principal Investigator:
          • Reem Karmali, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Recruiting
        • Indiana Blood and Marrow Transplantation
        • Principal Investigator:
          • Anand Tandra, MD
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • IU Simon Comprehensive Cancer Center
        • Principal Investigator:
          • Varun Mittal, MD
    • Kansas
      • Kansas City, Kansas, United States, 66205
        • Active, not recruiting
        • The University of Kansas Hospital
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky Medical Center
        • Principal Investigator:
          • Chaitanya Iragavarapu, MD
      • Louisville, Kentucky, United States, 40207
        • Recruiting
        • Norton Cancer Institute
        • Principal Investigator:
          • Don Stevens, MD
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University of Louisville Health Brown Cancer Center
        • Principal Investigator:
          • Hassaan Yasin, MD
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland Greenebaum Comprehensive Cancer Center
        • Principal Investigator:
          • Jean Yared, MD
      • Bethesda, Maryland, United States, 20817
        • Recruiting
        • The Center for Cancer and Blood Disorders
        • Principal Investigator:
          • Ralph Boccia, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Jeremy Abramson, MD
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Principal Investigator:
          • Michael Leukam, MD
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • University of Missouri - Ellis Fischel Cancer Center
        • Principal Investigator:
          • Gerhard Hildebrandt, MD
      • Kansas City, Missouri, United States, 64132
        • Recruiting
        • MidAmerica Cancer Care
        • Principal Investigator:
          • Jaswinder Singh, MD
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine - Siteman Cancer Center
        • Principal Investigator:
          • Nancy Bartlett, MD
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Recruiting
        • Astera Cancer Care
        • Principal Investigator:
          • Edward Licitra, MD
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center
        • Principal Investigator:
          • Lori Leslie, MD
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Principal Investigator:
          • Matthew Matasar, MD
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center and New York-Presbyterian Hospital
        • Principal Investigator:
          • Ran Reshef, MD
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester Medical Center
        • Principal Investigator:
          • Patrick Reagan, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Novant Health Cancer Institute- Hematology
        • Principal Investigator:
          • Alan Skarbnik, MD
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke Blood Cancer Center
        • Principal Investigator:
          • Mitchell Horwitz, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati Medical Center
        • Principal Investigator:
          • Tahir Latif, MD
      • Cincinnati, Ohio, United States, 45236
        • Recruiting
        • Oncology Hematology Care - Kenwood
        • Principal Investigator:
          • Ahmed Galal, MD
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Principal Investigator:
          • Paolo Caimi, MD
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Oncology Associates of Oregon
        • Principal Investigator:
          • Jeff Sharman, MD
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health And Science University
        • Principal Investigator:
          • Richard Maziarz, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Recruiting
        • Fox Chase Cancer Center
        • Principal Investigator:
          • Rashmi Khanal, MD
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • West Penn Hospital
        • Principal Investigator:
          • Thomas Curley, MD
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Cancer Institute
        • Principal Investigator:
          • Waqas Jehangir, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Principal Investigator:
          • Andrew Jallouk, MD
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Texas Oncology - Central South
        • Principal Investigator:
          • Jason Melear, MD
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Texas Oncology - Dallas Fort Worth
        • Principal Investigator:
          • Houston Holmes, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Principal Investigator:
          • Jason Westin, MD
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Texas Transplant Institute
        • Principal Investigator:
          • Nosha Farhadfar, MD
      • Tyler, Texas, United States, 75702
        • Recruiting
        • Texas Oncology - Tyler
        • Principal Investigator:
          • Habte Yimer, MD
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute, University of Utah
        • Principal Investigator:
          • Lindsey Fitzgerald, MD
      • Salt Lake City, Utah, United States, 84142
        • Recruiting
        • Intermountain Health LDS Hospital
        • Principal Investigator:
          • Bradley Hunter, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia
        • Principal Investigator:
          • Indumathy Varadarajan, MD
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Virginia Cancer Specialists
        • Principal Investigator:
          • Mitul Gandhi, MD
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Virginia Oncology Associates - Norfolk
        • Principal Investigator:
          • Gary Simmons, MD
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Swedish Cancer Institute
        • Principal Investigator:
          • Matthew Schwede, MD
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center
        • Principal Investigator:
          • Ryan Lynch, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cemacabtagene ansegedleucel
Participants receive cemacabtagene ansegedleucel following lymphodepletion regimen comprised of fludarabine and cyclophosphamide.
Drug: Fludarabine
Chemotherapy for lymphodepletion
Other Names:
  • Fludara®
Drug: Cyclophosphamide
Chemotherapy for lymphodepletion
Other Names:
  • Cytoxan®
Genetic: cemacabtagene ansegedleucel
An allogeneic CAR T cell therapy targeting CD19
Other Names:
  • cema-cel
Device: 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 Names:
  • Foresight Lymphoma MRD Therapy Selection Test
Other: Observation
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™
A diagnostic test intended to identify patients with minimal residual disease at the end of first line treatment for LBCL.
Other Names:
  • Foresight Lymphoma MRD Therapy Selection Test

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival per independent review committee assessment
Time Frame: Up to 60 months
Up to 60 months
Overall survival
Time Frame: Up to 60 months
Up to 60 months
Incidence and severity of adverse events and their relationship to cemacabtagene ansegedleucel and ALLO-647
Time Frame: Up to 60 months
Adverse events, treatment emergent adverse events, serious adverse events, and adverse events of special interest evaluated by the investigator based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CRS and ICANS will be graded using ASTCT.
Up to 60 months
Incidence and severity of laboratory toxicities related to cemacabtagene ansegedleucel and ALLO-647
Time Frame: Up to 60 months
Change from baseline value and NCI toxicity grading of laboratory values outside of normal ranges using CTCAE version 5.0.
Up to 60 months
Minimal residual disease clearance
Time Frame: Up to 60 months
Up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allogene Therapeutics

Collaborators

Natera, Inc.
Foresight Diagnostics, Inc.

Investigators

  • Study Director: Allogene Study Director, Allogene Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2032

Study Registration Dates

First Submitted

June 26, 2024

First Submitted That Met QC Criteria

July 11, 2024

First Posted (Actual)

July 15, 2024

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALLO-501A-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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