Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL (NCT06500273) | Clinical Trial Compass
RecruitingPhase 2
Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
United States250 participantsStarted 2024-06-18
Plain-language 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 CLARITYâ„¢ Investigational Use Only (IUO) MRD test, powered by PhasED-Seqâ„¢. 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 participate
Age range18 Years
SexALL
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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.
Exclusion criteria
✕
What they're measuring
1
Event-free survival per independent review committee assessment
. 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.