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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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.

Where this trial is running

• Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
• Genesis Cancer and Blood Institute, Hot Springs, Arkansas, United States
• Alta Bates Summit Medical Center, Berkeley, California, United States
• City of Hope, Duarte, California, United States
• Cedars-Sinai Medical Center, Los Angeles, California, United States
• University of California, Los Angeles, Los Angeles, California, United States
• University of California, Davis Comprehensive Cancer Center, Sacramento, California, United States
• University of California, San Diego, San Diego, California, United States
• University of California, San Francisco, San Francisco, California, United States
• Rocky Mountain Cancer Centers, Denver, Colorado, United States
• Medical Oncology Hematology Consultants, Newark, Delaware, United States
• MedStar Georgetown University Hospital, Washington D.C., District of Columbia, United States

+ 65 more sites.

Who to contact

Allogene Therapeutics, Inc · +1 415-604-5696 · clinicaltrials@allogene.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06500273.