NCT07398963

Clinical Study of Oncolytic Vaccinia VIrus Delivering Targeted CD19 in Vivo CAR-T/M Therapy for Refractory/Relapsed B-cell Lymphoma

Exploratory Study of Oncolytic Vaccinia VIrus-Delivered Targeted CD19 In Vivo CAR-T/M Therapy for Refractory/Relapsed B-Cell Lymphoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To study the safety and effectiveness of oncolytic Vaccinia VIrus-Delivered Targeted CD19 In Vivo CAR-T/M Therapy for Refractory/Relapsed B-Cell Lymphoma

Detailed description

This is a single-arm, dose-escalation, non-randomized, multicenter, dose-escalation exploratory study aimed at evaluating the safety and efficacy of a novel CD19-CAR oncolytic vaccinia virus (RGV005) in patients with B-cell lymphoma. The study included two groups: (1) intratumoral injection group (12-24 patients); (2) intravenous injection group (12-24 patients). A standard 3×3 design will be used to conduct a single-dose escalation safety and tolerability trial. Patients will be assigned to one of four dose groups in ascending order: Dose Group 1 (1×10\^8 pfu), Dose Group 2 (3×10\^8 pfu), Dose Group 3 (1×10\^9 pfu), and Dose Group 4 (3×10\^9 pfu). Each dose group plans to recruit 3 subjects. After completing the treatment and the month-3 assessment visit, subjects will enter the long-term follow-up period, which will last for 3 years after administration for each patient.

Conditions

• Refractory/Relapsed B-cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	CD19-CAR novel oncolytic vaccinia virus	Injection of CD19-CAR novel oncolytic vaccinia virus which carrying the CD19-CAR gene (RGV005) is designed to locally induce the in situ generation of CAR-T and CAR-M cells in tumors for precise lymphoma killing.

Timeline

• Start date: 2026-02-01
• Primary completion: 2029-07-01
• Completion: 2029-10-01
• First posted: 2026-02-10
• Last updated: 2026-02-10

Locations

1 site across 1 country: China