Clinical Research Directory

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

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

Connected Blood Pressure Monitoring in Patients With Hematologic Malignancies Initiating Covalent BTK Inhibitors

This pilot prospective study aims to evaluate adherence to home blood pressure monitoring using connected blood pressure (BP) devices in patients with malignant B-cell hemopathies initiating covalent Bruton tyrosine kinase inhibitors (cBTKi). The objective is to determine whether digital BP monitoring improves early detection and management of BTKi-induced hypertension over 6 months.

JWCAR239 in Patients With B Cell Non-Hodgkin Lymphoma

JWCAR239 is a CD19/CD20 CAR-T product. This trial is intended to evaluate the safety, PK/PD and efficacy of JWCAR239 in patients with B Cell Non-Hodgkin Lymphoma (B-NHL)

Study to Assess Clinical Characteristics and Outcome of Patients with Marginal Zone Lymphomas

This is a purely retrospective and observational monocentric study