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Large B-cell LymphomaPhase 2ALPHA3NCT06500273

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

A Phase 2 study testing cemacabtagene ansegedleucel, Fludarabine and Cyclophosphamide in people with Large B-cell Lymphoma, run by Allogene Therapeutics at 86 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Large B-cell Lymphoma
What is being tested?
cemacabtagene ansegedleucel, Fludarabine and Cyclophosphamide
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
86 sitesin 4 countries
Study dates
18 Jun 2024to Dec 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
  • Participant achieved CR, or PR suitable for observation, at the end of first line therapy based on PET/CT evaluation
  • Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™, is positive.
  • Adult participants ≥18 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • Adequate hematological, renal, hepatic, pulmonary, and cardiac function
  • Non-hematologic toxicities related to prior therapy must be recovered to baseline or grade ≤1.

Who cannot join

  • 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.
  • Prior treatment with anti-CD19 targeted therapies.
  • Anti-cancer treatment, including radiation, after end of treatment PET/CT and/or MRD testing is performed.
  • Active and clinically significant autoimmune disease.
  • Active systemic bacterial, fungal, or viral infections requiring systemic treatment.
  • History of another primary malignancy or bone marrow disorder (e.g., myelofibrosis, smoldering multiple myeloma) within 3 years prior to enrollment.

Trial locations and contacts

86 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Allogene Therapeutics, Inc contact

+1 415-604-5696

clinicaltrials@allogene.com

86 sites in 4 countries

United States64 sites, 62 recruiting

  • Winship Cancer Institute - Emory University

    Atlanta, Georgia, 30322

    Active, not recruiting

  • Augusta University Georgia Cancer Center

    Augusta, Georgia, 30912

    Locke Bryan, MD

    Recruiting

  • Texas Oncology - Central South

    Austin, Texas, 78705

    Jason Melear, MD

    Recruiting

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

    Jean Yared, MD

    Recruiting

  • Alta Bates Summit Medical Center

    Berkeley, California, 94704

    Oleg Krijanovski, MD

    Recruiting

  • The Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

    Ralph Boccia, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Jeremy Abramson, MD

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Michael Leukam, MD

    Recruiting

  • Novant Health Cancer Institute- Hematology

    Charlotte, North Carolina, 28204

    Alan Skarbnik, MD

    Recruiting

  • University of Virginia

    Charlottesville, Virginia, 22903

    Indumathy Varadarajan, MD

    Recruiting

  • Northwestern University - Feinberg School of Medicine

    Chicago, Illinois, 60611

    Reem Karmali, MD

    Recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60612

    Sunita Nathan, MD

    Recruiting

  • Oncology Hematology Care - Kenwood

    Cincinnati, Ohio, 45236

    Ahmed Galal, MD

    Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

    Tahir Latif, MD

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Paolo Caimi, MD

    Recruiting

  • University of Missouri - Ellis Fischel Cancer Center

    Columbia, Missouri, 65212

    Gerhard Hildebrandt, MD

    Recruiting

  • Texas Oncology - Dallas Fort Worth

    Dallas, Texas, 75203

    Houston Holmes, MD

    Recruiting

  • City of Hope

    Duarte, California, 91010

    Geoffrey Shouse, MD

    Recruiting

  • Duke Blood Cancer Center

    Durham, North Carolina, 27705

    Mitchell Horwitz, MD

    Recruiting

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

    Edward Licitra, MD

    Recruiting

  • Oncology Associates of Oregon

    Eugene, Oregon, 97401

    Jeff Sharman, MD

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Mitul Gandhi, MD

    Recruiting

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46804

    Sunil Babu, MD

    Recruiting

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

    Matthew Ulrickson, MD

    Recruiting

  • John Theurer Cancer Center

    Hackensack, New Jersey, 07601

    Lori Leslie, MD

    Recruiting

  • Genesis Cancer and Blood Institute

    Hot Springs, Arkansas, 71913

    Stephen Divers, MD

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Jason Westin, MD

    Recruiting

  • IU Simon Comprehensive Cancer Center

    Indianapolis, Indiana, 46202

    Varun Mittal, MD

    Recruiting

  • Indiana Blood and Marrow Transplantation

    Indianapolis, Indiana, 46237

    Anand Tandra, MD

    Recruiting

  • The University of Kansas Hospital

    Kansas City, Kansas, 66205

    Active, not recruiting

  • MidAmerica Cancer Care

    Kansas City, Missouri, 64132

    Jaswinder Singh, MD

    Recruiting

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536

    Chaitanya Iragavarapu, MD

    Recruiting

  • Rocky Mountain Cancer Centers

    Lone Tree, Colorado, 80124

    John Burke, MD

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Akil Merchant, MD

    Recruiting

  • University of California, Los Angeles

    Los Angeles, California, 90095

    Sven DeVos, MD

    Recruiting

  • University of Louisville Health Brown Cancer Center

    Louisville, Kentucky, 40202

    Hassaan Yasin, MD

    Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

    Don Stevens, MD

    Recruiting

  • Miami Cancer Institute at Baptist Health, Inc.

    Miami, Florida, 33176

    Yuliya Linhares, MD

    Recruiting

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455

    Veronica Bachanova, MD

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Andrew Jallouk, MD

    Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

    Matthew Matasar, MD

    Recruiting

  • Columbia University Irving Medical Center and New York-Presbyterian Hospital

    New York, New York, 10032

    Ran Reshef, MD

    Recruiting

  • Medical Oncology Hematology Consultants

    Newark, Delaware, 19713

    Jamal Misleh, MD

    Recruiting

  • Virginia Oncology Associates - Norfolk

    Norfolk, Virginia, 23502

    Gary Simmons, MD

    Recruiting

  • Advent Health Cancer Institute

    Orlando, Florida, 32804

    Rushang Patel, MD

    Recruiting

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

    Abhishek Chilkulwar, MD

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Rashmi Khanal, MD

    Recruiting

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

    Prerna Mewawalla, MD

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Richard Maziarz, MD

    Recruiting

  • University of Rochester Medical Center

    Rochester, New York, 14642

    Patrick Reagan, MD

    Recruiting

  • University of California, Davis Comprehensive Cancer Center

    Sacramento, California, 95817

    Naseem Esteghamat, MD

    Recruiting

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah, 84112

    Lindsey Fitzgerald, MD

    Recruiting

  • Intermountain Health LDS Hospital

    Salt Lake City, Utah, 84142

    Bradley Hunter, MD

    Recruiting

  • Texas Transplant Institute

    San Antonio, Texas, 78229

    Nosha Farhadfar, MD

    Recruiting

  • University of California, San Diego

    San Diego, California, 92037

    Ayad Hamdan, MD

    Recruiting

  • University of California, San Francisco

    San Francisco, California, 94143

    Michael Spinner, MD

    Recruiting

  • Swedish Cancer Institute

    Seattle, Washington, 98104

    Matthew Schwede, MD

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Ryan Lynch, MD

    Recruiting

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

    Waqas Jehangir, MD

    Recruiting

  • Oncology Hematology Associates

    Springfield, Missouri, 65807

    Robert Ellis, MD

    Recruiting

  • Washington University School of Medicine - Siteman Cancer Center

    St Louis, Missouri, 63110

    Nancy Bartlett, MD

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Frederick Locke, MD

    Recruiting

  • Texas Oncology - Tyler

    Tyler, Texas, 75702

    Habte Yimer, MD

    Recruiting

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

    Kieron Dunleavy, MD

    Recruiting

Other trials in United States

South Korea9 sites, 9 recruiting

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

    Hyeon-Seok Eom, MD

    Recruiting

  • Chonnam National University, Hwasun Hospital

    Hwasun, Jeollanam-do, 58128

    Deok-Hwan Yang, MD

    Recruiting

  • Pusan National University Hospital

    Seogu, Busan, South Korea

    Shin Ho-jin, MD

    Recruiting

  • Seoul National University

    Seoul, Seoul, 03080

    Youngil Koh, MD

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul, 03722

    Jin Seok Kim, MD

    Recruiting

  • Asan Medical Center

    Seoul, Seoul, 05505

    Dok Yoon, MD

    Recruiting

  • Samsung Medical Center

    Seoul, Seoul, 06351

    Seok Kim, MD

    Recruiting

  • The Catholic University of Korea, Yeouido St. Mary's Hospital

    Seoul, Seoul, 07345

    Youngwoo Jeon, MD

    Recruiting

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499

    Seong Huyn Jeong, MD

    Recruiting

Other trials in South Korea

Australia7 sites, 7 recruiting

  • Icon Cancer Centre Wesley

    Auchenflower, Queensland, 4066

    Karthik Nath, MD

    Recruiting

  • Monash Health

    Clayton, Victoria, 3168

    Danielle Oh, MD

    Recruiting

  • St. Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

    Matthew Ku, MD

    Recruiting

  • Austin Health

    Heidelberg, Victoria, 3084

    Denise Lee, MD

    Recruiting

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

    Anna Johnston, MD

    Recruiting

  • Hollywood Private Hospital

    Nedlands, Western Australia, 6009

    Chan Cheah, MD

    Recruiting

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

    Aung Thant, MD

    Recruiting

Other trials in Australia

Canada6 sites, 6 recruiting

  • Arthur JE Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

    Mona Shafey, MD

    Recruiting

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9

    Mahmoud Elsawy, MD

    Recruiting

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

    Montreal, Quebec, H1T 2M4

    Sandra Cohen, MD

    Recruiting

  • CHUM - University of Montreal Hospital Centre

    Montreal, Quebec, H2X 0A9

    Xavier Deschenes-Simard, MD

    Recruiting

  • Hopital de'L'Enfant-Jesus

    Québec, Quebec, G1R 2J6

    Christopher Lemieux, MD

    Recruiting

  • Princess Margaret Cancer Centre - University Health Network

    Toronto, Ontario, M5G 1Z5

    John Kuruvilla, MD

    Recruiting

Other trials in Canada

About this study

Official title: 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.

Being tested
cemacabtagene ansegedleucel, Fludarabine, Cyclophosphamide, Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™
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
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Neoplasm, Residual

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cemacabtagene ansegedleucelGenetic

    Also called cema-cel

    An allogeneic CAR T cell therapy targeting CD19

  • FludarabineDrug

    Also called Fludara®

    Chemotherapy for lymphodepletion

  • CyclophosphamideDrug

    Also called Cytoxan®

    Chemotherapy for lymphodepletion

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

    Also called Foresight Lymphoma MRD Therapy Selection Test

    A diagnostic test intended to identify patients with minimal residual disease at the end of first line treatment for LBCL.

Study groups in NCT06500273
Study groupRoleWhat they receive
cemacabtagene ansegedleucelExperimentalParticipants receive cemacabtagene ansegedleucel following lymphodepletion regimen comprised of fludarabine and cyclophosphamide.
Receives: Genetic: cemacabtagene ansegedleucel; Drug: Fludarabine; Drug: Cyclophosphamide; Device: Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™
ObservationOtherParticipants do not receive any study treatments. They are observed as per the current standard of care.
Receives: Device: Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-free survival per independent review committee assessment

    Measured: Up to 60 months

Secondary outcomes (5)

  1. Progression-free survival per independent review committee assessment

    Measured: Up to 60 months

  2. Overall survival

    Measured: Up to 60 months

  3. Incidence and severity of adverse events and their relationship to cemacabtagene ansegedleucel and ALLO-647

    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.

    Measured: Up to 60 months

  4. Incidence and severity of laboratory toxicities related to cemacabtagene ansegedleucel and ALLO-647

    Change from baseline value and NCI toxicity grading of laboratory values outside of normal ranges using CTCAE version 5.0.

    Measured: Up to 60 months

  5. Minimal residual disease clearance

    Measured: Up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2024
  2. Study start18 Jun 2024
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06500273
Sponsor's protocol ID
ALLO-501A-202
Acronym
ALPHA3
Status last verified
Oct 2026
First submitted
26 Jun 2024
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cemacabtagene ansegedleucel, Fludarabine and Cyclophosphamide in people with Large B-cell Lymphoma, run by Allogene Therapeutics at 86 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, South Korea, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Allogene Therapeutics, Inc (+1 415-604-5696, clinicaltrials@allogene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free survival per independent review committee assessment (time frame: Up to 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06500273.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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