Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
ConditionLarge B-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAllogene Therapeutics
About this 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- cemacabtagene ansegedleucel
- Fludarabine
- Cyclophosphamide
- Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov