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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
cemacabtagene ansegedleucel
GeneticAn allogeneic CAR T cell therapy targeting CD19
Fludarabine
DrugChemotherapy for lymphodepletion
Cyclophosphamide
DrugChemotherapy for lymphodepletion
Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™
DeviceA diagnostic test intended to identify patients with minimal residual disease at the end of first line treatment for LBCL.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: cemacabtagene ansegedleucelExperimental treatment 4 interventions
Group B: ObservationOther 1 intervention
Trial outcomes
Primary outcomes
1
Event-free survival per independent review committee assessment
Time frame
Up to 60 monthsSecondary outcomes
1
Progression-free survival per independent review committee assessment
Time frame
Up to 60 months2
Overall survival
Time frame
Up to 60 months3
Incidence and severity of adverse events and their relationship to cemacabtagene ansegedleucel and ALLO-647
Adverse events, treatment emergent adverse events, serious adverse events, and adverse events of special interest evaluated by the investigator based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CRS and ICANS will be graded using ASTCT.
Time frame
Up to 60 months4
Incidence and severity of laboratory toxicities related to cemacabtagene ansegedleucel and ALLO-647
Change from baseline value and NCI toxicity grading of laboratory values outside of normal ranges using CTCAE version 5.0.
Time frame
Up to 60 monthsSponsors and contacts
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Source ClinicalTrials.gov