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A Phase II Study to Evaluate the Efficacy of UF-KURE19 Cells in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas

NCT07713459 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2026-07-20

No results posted yet for this study

Summary

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

Conditions

  • Lymphoma Nonhodgkin
  • Marginal Zone B Cell Lymphoma
  • Diffuse Large B Cell Lymphoma (DLBCL)
  • Follicular B-cell Non-Hodgkin's Lymphoma
  • CAR T Cell Therapy

Interventions

BIOLOGICAL

CART Infusion

UF-KURE19 are CD19 CAR-T cells that are manufactured using an Ultra-fast less than 1 day process

Sponsors & Collaborators

  • Kure Cells, INC

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2029-08-31
Completion
2029-11-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07713459 on ClinicalTrials.gov