NCT07382817

Phase 1 Study of JV-394 Autologous Anti-CD94 CAR T for r/r CD94+ T/NK Cell Neoplasms

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 Objective: The exploratory objectives are to assess the cellular kinetics and pharmacodynamic effects of JV-394 anti-CD94 CAR T cell product and to evaluate biomarkers associated with response, resistance, and toxicity after administration of CAR T product in blood and tumor samples.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	JV-394	Given by infusion

Timeline

• Start date: 2026-02-18
• Primary completion: 2029-12-09
• Completion: 2031-12-09
• First posted: 2026-02-03
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study