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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
An allogeneic CAR T cell therapy targeting CD19
Chemotherapy for lymphodepletion
Chemotherapy for lymphodepletion
A diagnostic test intended to identify patients with minimal residual disease at the end of first line treatment for LBCL.
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
RECRUITINGGenesis Cancer and Blood Institute
Hot Springs, Arkansas, United States
RECRUITINGAlta Bates Summit Medical Center
Berkeley, California, United States
RECRUITINGCity of Hope
Duarte, California, United States
Event-free survival per independent review committee assessment
Time frame: Up to 60 months
Progression-free survival per independent review committee assessment
Time frame: Up to 60 months
Overall survival
Time frame: Up to 60 months
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 months
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 months
Minimal residual disease clearance
Time frame: Up to 60 months
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Cedars-Sinai Medical Center
Los Angeles, California, United States
RECRUITINGUniversity of California, Los Angeles
Los Angeles, California, United States
RECRUITINGUniversity of California, Davis Comprehensive Cancer Center
Sacramento, California, United States
RECRUITINGUniversity of California, San Diego
San Diego, California, United States
RECRUITINGUniversity of California, San Francisco
San Francisco, California, United States
RECRUITINGRocky Mountain Cancer Centers
Denver, Colorado, United States
RECRUITING...and 49 more locations