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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment250 people
  • Recruiting US sites62
  • SponsorAllogene Therapeutics
  • RegistryNCT06500273

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL: a one-minute explainerNCT065002731 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join if

  • Key Inclusion Criteria:
  • 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.
  • Key Exclusion Criteria:
  • 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.

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

  • cemacabtagene ansegedleucel (Genetic): An allogeneic CAR T cell therapy targeting CD19
  • Fludarabine (Drug): Chemotherapy for lymphodepletion
  • Cyclophosphamide (Drug): Chemotherapy for lymphodepletion
  • Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™ (Device): A diagnostic test intended to identify patients with minimal residual disease at the end of first line treatment for LBCL.

The study

Treatment groups

Randomized · Parallel · masking: None

cemacabtagene ansegedleucel (Experimental)

Participants receive cemacabtagene ansegedleucel following lymphodepletion regimen comprised of fludarabine and cyclophosphamide.

Observation (Other)

Participants do not receive any study treatments. They are observed as per the current standard of care.

Goals

What the study measures

Main goals

  • Event-free survival per independent review committee assessment (Up to 60 months)

Other goals

  • Progression-free survival per independent review committee assessment
  • Overall survival
  • Incidence and severity of adverse events and their relationship to cemacabtagene ansegedleucel and ALLO-647
  • Incidence and severity of laboratory toxicities related to cemacabtagene ansegedleucel and ALLO-647
  • Minimal residual disease clearance

Planned enrollment: 250 (estimated).

Where

Recruiting US sites

  • Banner MD Anderson Cancer Center, Gilbert, Arizona
  • Genesis Cancer and Blood Institute, Hot Springs, Arkansas
  • Alta Bates Summit Medical Center, Berkeley, California
  • City of Hope, Duarte, California
  • Cedars-Sinai Medical Center, Los Angeles, California
  • University of California, Los Angeles, Los Angeles, California
  • University of California, Davis Comprehensive Cancer Center, Sacramento, California
  • University of California, San Diego, San Diego, California
  • University of California, San Francisco, San Francisco, California
  • Rocky Mountain Cancer Centers, Lone Tree, Colorado
  • Medical Oncology Hematology Consultants, Newark, Delaware
  • MedStar Georgetown University Hospital, Washington D.C., District of Columbia
  • Miami Cancer Institute at Baptist Health, Inc., Miami, Florida
  • Advent Health Cancer Institute, Orlando, Florida
  • Orlando Health Cancer Institute, Orlando, Florida
  • Moffitt Cancer Center, Tampa, Florida
  • Augusta University Georgia Cancer Center, Augusta, Georgia
  • Northwestern University - Feinberg School of Medicine, Chicago, Illinois
  • Rush University Medical Center, Chicago, Illinois
  • Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana
  • IU Simon Comprehensive Cancer Center, Indianapolis, Indiana
  • Indiana Blood and Marrow Transplantation, Indianapolis, Indiana
  • University of Kentucky Medical Center, Lexington, Kentucky
  • University of Louisville Health Brown Cancer Center, Louisville, Kentucky
  • Norton Cancer Institute, Louisville, Kentucky
  • University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, Maryland
  • The Center for Cancer and Blood Disorders, Bethesda, Maryland
  • Massachusetts General Hospital, Boston, Massachusetts
  • Beth Israel Deaconess Medical Center, Boston, Massachusetts
  • University of Minnesota Medical Center, Minneapolis, Minnesota
  • University of Missouri - Ellis Fischel Cancer Center, Columbia, Missouri
  • MidAmerica Cancer Care, Kansas City, Missouri
  • Oncology Hematology Associates, Springfield, Missouri
  • Washington University School of Medicine - Siteman Cancer Center, St Louis, Missouri
  • Astera Cancer Care, East Brunswick, New Jersey
  • John Theurer Cancer Center, Hackensack, New Jersey
  • Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey
  • Columbia University Irving Medical Center and New York-Presbyterian Hospital, New York, New York
  • University of Rochester Medical Center, Rochester, New York
  • Novant Health Cancer Institute- Hematology, Charlotte, North Carolina
  • Duke Blood Cancer Center, Durham, North Carolina
  • Oncology Hematology Care - Kenwood, Cincinnati, Ohio
  • University of Cincinnati Medical Center, Cincinnati, Ohio
  • Cleveland Clinic, Cleveland, Ohio
  • Oncology Associates of Oregon, Eugene, Oregon
  • Oregon Health and Science University, Portland, Oregon
  • Fox Chase Cancer Center, Philadelphia, Pennsylvania
  • West Penn Hospital, Pittsburgh, Pennsylvania
  • Avera Cancer Institute, Sioux Falls, South Dakota
  • Vanderbilt University Medical Center, Nashville, Tennessee
  • Texas Oncology - Central South, Austin, Texas
  • Texas Oncology - Dallas Fort Worth, Dallas, Texas
  • MD Anderson Cancer Center, Houston, Texas
  • Texas Transplant Institute, San Antonio, Texas
  • Texas Oncology - Tyler, Tyler, Texas
  • Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah
  • Intermountain Health LDS Hospital, Salt Lake City, Utah
  • University of Virginia, Charlottesville, Virginia
  • Virginia Cancer Specialists, Fairfax, Virginia
  • Virginia Oncology Associates - Norfolk, Norfolk, Virginia
  • Swedish Cancer Institute, Seattle, Washington
  • Fred Hutchinson Cancer Center, Seattle, Washington

22 recruiting sites outside the US. Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 1, 2026. Public record; not medical advice.

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