RecruitingPhase IIEN original

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Pacjenci z diagnozą chłoniaka z dużych komórek B (potwierdzoną badaniem histopatologicznym).
  • Pacjenci, którzy ukończyli pełne leczenie pierwszej linii (np. R-CHOP) zgodnie z planem.
  • Pacjenci, u których po leczeniu pierwszej linii uzyskano całkowitą lub częściową odpowiedź na leczenie, a następnie wykryto chorobę resztkową (MRD).
  • Pacjenci, którzy ukończyli 18 lat.
  • Pacjenci w dobrym ogólnym stanie zdrowia, mogący wykonywać codzienne czynności (stan sprawności ECOG 0 lub 1).
  • Pacjenci z wystarczająco dobrą funkcją krwi, nerek, wątroby, płuc i serca.
  • Dolegliwości niezwiązane z krwią, które wystąpiły po wcześniejszym leczeniu, muszą ustąpić lub być łagodne.

✗ Disqualifies

  • Chłoniak z zajęciem ośrodkowego układu nerwowego, chłoniak, który przekształcił się z innej choroby lub specyficzne typy chłoniaków.
  • Wcześniejsze leczenie ukierunkowane na antygen CD19.
  • Aktywne leczenie przeciwnowotworowe (w tym radioterapia) po zakończeniu leczenia pierwszej linii.
  • Ciężkie, aktywne choroby autoimmunologiczne.
  • Aktywne, poważne infekcje bakteryjne, grzybicze lub wirusowe wymagające leczenia ogólnego.
  • Inne choroby nowotworowe lub choroby szpiku kostnego w ciągu ostatnich 3 lat.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
June 29, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (77)

Banner MD Anderson Cancer Center

Gilbert, United States

Genesis Cancer and Blood Institute

Hot Springs, United States

Alta Bates Summit Medical Center

Berkeley, United States

City of Hope

Duarte, United States

Cedars-Sinai Medical Center

Los Angeles, United States

University of California, Los Angeles

Los Angeles, United States

University of California, Davis Comprehensive Cancer Center

Sacramento, United States

University of California, San Diego

San Diego, United States

University of California, San Francisco

San Francisco, United States

Rocky Mountain Cancer Centers

Denver, United States

Medical Oncology Hematology Consultants

Newark, United States

MedStar Georgetown University Hospital

Washington D.C., United States

Miami Cancer Institute at Baptist Health, Inc.

Miami, United States

Advent Health Cancer Institute

Orlando, United States

Orlando Health Cancer Institute

Orlando, United States

Moffitt Cancer Center

Tampa, United States

Augusta University Georgia Cancer Center

Augusta, United States

Northwestern University - Feinberg School of Medicine

Chicago, United States

Rush University Medical Center

Chicago, United States

Fort Wayne Medical Oncology and Hematology

Fort Wayne, United States

IU Simon Comprehensive Cancer Center

Indianapolis, United States

Indiana Blood and Marrow Transplantation

Indianapolis, United States

The University of Kansas Hospital

Kansas City, United States

University of Kentucky Medical Center

Lexington, United States

University of Louisville Health Brown Cancer Center

Louisville, United States

Norton Cancer Institute

Louisville, United States

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, United States

The Center for Cancer and Blood Disorders

Bethesda, United States

Massachusetts General Hospital

Boston, United States

Beth Israel Deaconess Medical Center

Boston, United States

University of Missouri - Ellis Fischel Cancer Center

Columbia, United States

MidAmerica Cancer Care

Kansas City, United States

Washington University School of Medicine - Siteman Cancer Center

St Louis, United States

Astera Cancer Care

East Brunswick, United States

John Theurer Cancer Center

Hackensack, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, United States

Columbia University Irving Medical Center and New York-Presbyterian Hospital

New York, United States

University of Rochester Medical Center

Rochester, United States

Novant Health Cancer Institute- Hematology

Charlotte, United States

Duke Blood Cancer Center

Durham, United States

Oncology Hematology Care - Kenwood

Cincinnati, United States

University of Cincinnati Medical Center

Cincinnati, United States

Cleveland Clinic

Cleveland, United States

Oncology Associates of Oregon

Eugene, United States

Oregon Health and Science University

Portland, United States

Fox Chase Cancer Center

Philadelphia, United States

West Penn Hospital

Pittsburgh, United States

Avera Cancer Institute

Sioux Falls, United States

Vanderbilt University Medical Center

Nashville, United States

Texas Oncology - Central South

Austin, United States

Texas Oncology - Dallas Fort Worth

Dallas, United States

MD Anderson Cancer Center

Houston, United States

Texas Transplant Institute

San Antonio, United States

Texas Oncology - Tyler

Tyler, United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, United States

Intermountain Health LDS Hospital

Salt Lake City, United States

University of Virginia

Charlottesville, United States

Virginia Cancer Specialists

Fairfax, United States

Virginia Oncology Associates - Norfolk

Norfolk, United States

Swedish Cancer Institute

Seattle, United States

Fred Hutchinson Cancer Center

Seattle, United States

Icon Cancer Centre Wesley

Auchenflower, Australia

Royal Hobart Hospital

Hobart, Australia

Monash Health

Clayton, Australia

St. Vincent's Hospital Melbourne

Fitzroy, Australia

Austin Health

Heidelberg, Australia

Hollywood Private Hospital

Nedlands, Australia

Arthur JE Child Comprehensive Cancer Centre

Calgary, Canada

Queen Elizabeth II Health Sciences Centre

Halifax, Canada

Princess Margaret Cancer Centre - University Health Network

Toronto, Canada

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

Montreal, Canada

CHUM - University of Montreal Hospital Centre

Montreal, Canada

Hopital de'L'Enfant-Jesus

Québec, Canada

Pusan National University Hospital

Seogu, South Korea

Samsung Medical Center

Gangnam-gu, South Korea

Seoul National University

Jongno-gu, South Korea

Asan Medical Center

Songpa-gu, South Korea

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.