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 (10×10⁶ cells for patients ≥50kg; 7×10⁶ cells for patients \<50kg) Complete disease response assessments at Day 90 post-infusion per Lugano criteria 3. Undergo safety monitoring including adverse event collection, laboratory tests, neurological exams, CAR-T persistence assays, and replication-competent lentivirus (RCL) testing throughout the study 4. Be followed long-term for up to 15 years post-infusion for gene therapy safety surveillance per FDA requirements
Male or female patients aged 18 years or older.
Participants must have histologically confirmed, CD19 positive (by IHC or flow cytometry) NHL at the most recent biopsy. If a previous CD19 targeting therapy was utilized, a biopsy should be available after this therapy demonstrating sustained CD19 expression.
ECOG Performance status ≤ 2.
Participants must exhibit measurable disease with at least one FDG avid lesion at enrollment per Lugano Criteria
Inclusion Criteria
Male or female patients aged 18 years or older.
Participants must have histologically confirmed, CD19 positive (by IHC or flow cytometry) NHL at the most recent biopsy. If a previous CD19 targeting therapy was utilized, a biopsy should be available after this therapy demonstrating sustained CD19 expression.
ECOG Performance status ≤ 2.
Single group
CART Infusion
Biological/VaccineUF-KURE19 are CD19 CAR-T cells that are manufactured using an Ultra-fast less than 1 day process
Complete Response Rate
Objective and Complete Response rates per Lugano Revised Response Criteria for R/R B-cell NHL
Duration of CR
To determine the duration of response in patients with Relapsed or Refractory Aggressive B Cell Non-Hodgkin Lymphoma treated with UF-KURE19.
Overall Survival
To determine the overall survival in patients with Relapsed or Refractory Aggressive B cell Non-Hodgkin Lymphoma treated with UF-KURE19.
Progression-Free Survival (PFS)
To determine PFS in patients with Relapsed or Refractory Aggressive B cell Non-Hodgkin Lymphoma treated with UF-KURE19.
Manufacturing Success Rate
Manufacturing success rate is defined as manufacturing process leading to an adequate product per protocol standards. We expect this outcome to occur in ≥75% of the products manufactured.
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