Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
Key facts
- Where
- Atlanta, Augusta, Austin, Baltimore, Berkeley, Bethesda, Boston, Charlotte, Charlottesville, Chicago, Cincinnati, Cleveland, Columbia, Dallas, Duarte, Durham, East Brunswick, Eugene, Fairfax, Fort Wayne, Gilbert, Hackensack, Hot Springs, Houston, Indianapolis, Kansas City, Lexington, Lone Tree, Los Angeles, Louisville, Miami, Minneapolis, Nashville, New Brunswick, New York, Newark, Norfolk, Orlando, Philadelphia, Pittsburgh, Portland, Rochester, Sacramento, Salt Lake City, San Antonio, San Diego, San Francisco, Seattle, Sioux Falls, Springfield, St Louis, Tampa, Tyler, and Washington D.C., United StatesSee the 64 sites
- Phase
- Phase 2
Where in United States
- Winship Cancer Institute, Emory UniversityAtlanta, United StatesNo longer taking part
- Augusta University, Georgia Cancer CenterAugusta, United StatesTaking people
- Texas Oncology - Central SouthAustin, United StatesTaking people
- University of Maryland Greenebaum Comprehensive Cancer CenterBaltimore, United StatesTaking people
- Alta Bates Summit Medical CenterBerkeley, United StatesTaking people
- The Center for Cancer and Blood DisordersBethesda, United StatesTaking people
- Beth Israel Deaconess Medical CenterBoston, United StatesTaking people
- Massachusetts General HospitalBoston, United StatesTaking people
- Novant Health Cancer Institute HematologyCharlotte, United StatesTaking people
- University of VirginiaCharlottesville, United StatesTaking people
- Northwestern University Feinberg School of MedicineChicago, United StatesTaking people
- Rush University Medical CenterChicago, United StatesTaking people
- Oncology Hematology Care - KenwoodCincinnati, United StatesTaking people
- University of Cincinnati Medical CenterCincinnati, United StatesTaking people
- Cleveland ClinicCleveland, United StatesTaking people
- University of Missouri - Ellis Fischel Cancer CenterColumbia, United StatesTaking people
- Texas Oncology - Dallas Fort WorthDallas, United StatesTaking people
- City of HopeDuarte, United StatesTaking people
- Duke Blood Cancer CenterDurham, United StatesTaking people
- Astera Cancer CareEast Brunswick, United StatesTaking people
- Oncology Associates of OregonEugene, United StatesTaking people
- Virginia Cancer SpecialistsFairfax, United StatesTaking people
- Fort Wayne Medical Oncology and HematologyFort Wayne, United StatesTaking people
- Banner MD Anderson Cancer CenterGilbert, United StatesTaking people
- John Theurer Cancer CenterHackensack, United StatesTaking people
- Genesis Cancer and Blood InstituteHot Springs, United StatesTaking people
- MD Anderson Cancer CenterHouston, United StatesTaking people
- Indiana Blood and Marrow TransplantationIndianapolis, United StatesTaking people
- IU Simon Comprehensive Cancer CenterIndianapolis, United StatesTaking people
- MidAmerica Cancer CareKansas City, United StatesTaking people
- The University of Kansas HospitalKansas City, United StatesNo longer taking part
- University of Kentucky Medical CenterLexington, United StatesTaking people
- Rocky Mountain Cancer CentersLone Tree, United StatesTaking people
- Cedars-Sinai Medical CenterLos Angeles, United StatesTaking people
- University of California, Los AngelesLos Angeles, United StatesTaking people
- Norton Cancer InstituteLouisville, United StatesTaking people
- University of Louisville Health Brown Cancer CenterLouisville, United StatesTaking people
- Miami Cancer Institute at Baptist Health, Inc.Miami, United StatesTaking people
- University of Minnesota Medical CenterMinneapolis, United StatesTaking people
- Vanderbilt University Medical CenterNashville, United StatesTaking people
- Rutgers Cancer Institute of New JerseyNew Brunswick, United StatesTaking people
- Columbia University Irving Medical Center and New York-Presbyterian HospitalNew York, United StatesTaking people
- Medical Oncology Hematology ConsultantsNewark, United StatesTaking people
- Virginia Oncology Associates - NorfolkNorfolk, United StatesTaking people
- Advent Health Cancer InstituteOrlando, United StatesTaking people
- Orlando Health Cancer InstituteOrlando, United StatesTaking people
- Fox Chase Cancer CenterPhiladelphia, United StatesTaking people
- West Penn HospitalPittsburgh, United StatesTaking people
- Oregon Health and Science UniversityPortland, United StatesTaking people
- University of Rochester Medical CenterRochester, United StatesTaking people
- University of California Davis Comprehensive Cancer CenterSacramento, United StatesTaking people
- Huntsman Cancer Institute/University of UtahSalt Lake City, United StatesTaking people
- Intermountain Health LDS HospitalSalt Lake City, United StatesTaking people
- Texas Transplant InstituteSan Antonio, United StatesTaking people
- University of California San DiegoSan Diego, United StatesTaking people
- University of California San FranciscoSan Francisco, United StatesTaking people
- Fred Hutchinson Cancer CenterSeattle, United StatesTaking people
- Swedish Cancer InstituteSeattle, United StatesTaking people
- Avera Cancer InstituteSioux Falls, United StatesTaking people
- Oncology Hematology AssociatesSpringfield, United StatesTaking people
- Washington University School of Medicine - Siteman Cancer CenterSt Louis, United StatesTaking people
- Moffitt Cancer CenterTampa, United StatesTaking people
- Texas Oncology - TylerTyler, United StatesTaking people
- MedStar Georgetown University HospitalWashington D.C., United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Allogene Therapeutics
- Trial code
- NCT06500273
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Prior treatment with anti-CD19 targeted therapies; History of another primary malignancy or bone marrow disorder (e.g., myelofibrosis, smoldering multiple myeloma) within 3 years prior to enrollment; 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; 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.