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

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

Trial Details

NCT ID

NCT06500273

Phase

PHASE2

Sponsor

Allogene Therapeutics

Status

RECRUITING

Cancer Type

Non-Hodgkin Lymphoma Lymphoma

Interventions

cemacabtagene ansegedleucel
Fludarabine
Cyclophosphamide
Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™

Locations (sample)

Gilbert, Arizona, United States|33.35283,-111.78903
Hot Springs, Arkansas, United States|34.5037,-93.05518
Berkeley, California, United States|37.87159,-122.27275
Duarte, California, United States|34.13945,-117.97729
Los Angeles, California, United States|34.05223,-118.24368

Key Eligibility Criteria

LBCL per WHO 2017 including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and primary mediastinal B-cell lymphoma histologically confi…
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 …
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.

For full eligibility, visit ClinicalTrials.gov.

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