Condition: Lymphoma Nonhodgkin · Marginal Zone B Cell Lymphoma · Diffuse Large B Cell Lymphoma (DLBCL) · Sponsor: Kure Cells, INC
The goal of this Phase II single-arm, open-label clinical trial is to evaluate whether UF-KURE19, an autologous CD19-directed CAR-T cell therapy manufactured t…The goal of this Phase II single-arm, open-label clinical trial is to evaluate whether UF-KURE19, an autologous CD19-directed CAR-T cell therapy manufactured through an ultra-fast (less than 1 day) process, can treat adult patients (18 years and older, male or female) with relapsed or refractory B-cell Non-Hodgkin Lymphoma (NHL), including Large B-Cell Lymphoma (LBCL), Follicular Lymphoma (FL), and Marginal Zone Lymphoma (MZL). The participants will be divided in two cohorts: 81 participants in Cohort 1: Large B-Cell Lymphoma (LBCL) 24 participants in Cohort 2: Follicular Lymphoma (FC) and Marginal Zone Lymphoma (MZL) The main questions it aims to answer are: 1. Can UF-KURE19 achieve a clinically meaningful complete response rate (CRR) of ≥ 45% in patients with relapsed/refractory LBCL at Day 90 post-infusion, per Lugano Revised Response Criteria? 2. Can UF-KURE19 achieve a CRR of ≥ 60% in patients with relapsed/refractory Follicular or Marginal Zone Lymphoma at Day 90 post-infusion? There is no comparison group. This is a single-arm study, (all participants receive UF-KURE19) with 2 cohorts as outlined above. Participants will: 1. Undergo leukapheresis for collection of their own T cells, which will be used to manufacture UF-KURE19. 2. Subsequently they will receive a single intravenous infusion of UF-KURE19 (1…
This description comes directly from the study's public registry record.
Daniel Couriel, MD, MS, MBA · 7343539036 · daniel@cellserveglobal.net
Ola Soliman, MD · 647-865-0773 · olaselkadi@gmail.com
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Source record: clinicaltrials.gov/study/NCT07713459