A Phase 1 Safety and Efficacy Study of JV-394 Autologous Anti-CD94 Chimeric Antigen Receptor T Cell Therapy in Patients With Relapsed or Refractory CD94+ T/NK Cell Neoplasms
M.D. Anderson Cancer Center
Summary
The goal of this clinical research study is to find the highest tolerable dose of JV-394 (a type of autologous CAR-T cell therapy) that can be given to patients who have T/NK cell lymphoma that is relapsed or refractory. The safety and possible side effects of JV-394 will also be studied.
Description
Primary Objective: The primary objective is to determine the safety and identify the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of JV-394 in patients with CD94+ r/r T/NK cell malignancies. Secondary Objective: The secondary objectives are to determine the efficacy in adults with r/r CD94+ T/NK cell malignancies at the MTD or RP2D of JV-394. Secondary end points include overall response rate (ORR; including CR+PR) and CR rate as defined by Lugano or Olsen Criteria, duration of response (DOR), progression free survival (PFS) and overall survival (OS).41,42 Exploratory Ob…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. ≥18 years of age. 2. Confirmed T/NK cell malignancies as per local histopathological assessment. 3. Relapsed or refractory disease after at least one line of systemic therapy or intolerant to standard therapy for their cancer. 4. Eligible histologies include: extranodal NK/TCL, hepatosplenic TCL, primary cutaneous CD8+ aggressive epidermotropic cytotoxic TCL, subcutaneous panniculitis-like TCL, monomorphic epitheliotropic intestinal TCL, enteropathy-associated TCL, primary cutaneous γδ TCL, peripheral TCL cytotoxic type, Epstein-Barr virus (EBV)+ nodal T/NK cell lymphom…
Interventions
- DrugJV-394
Given by infusion
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas