A Phase I/II Trial of VUM02 Injection for Steroid-refractory Acute Graft-versus-host Disease (SR-aGvHD) Treatment

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

149

Participants

Timeline

Start Date

January 31, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2028

Conditions
Steroid-refractory Acute Graft-versus-host Disease
Interventions
DRUG

VUM02 Injection (UC-MSCs)+BAT

"The dose-escalation phase (phase I):~Single dose escalation Phase 1a study: 3 dose levels of a single IV infusion; Multiple dose escalation Phase 1b study: 3 dose levels of twice weekly for 4 consecutive week.~The dose-expansion phase (phase II):~-Two dose groups will be selected by the investigator and the sponsor based on the results of the Phase 1b study, twice a week for 4 consecutive weeks for a total of 8 doses."

OTHER

The control group with Best Available Therapy (BAT)

According to BAT scheme, the drug administration is determined by PI according to the condition of the patients.

Trial Locations (1)

430000

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan

All Listed Sponsors
lead

Wuhan Optics Valley Vcanbiopharma Co., Ltd.

INDUSTRY

NCT06677255 - A Phase I/II Trial of VUM02 Injection for Steroid-refractory Acute Graft-versus-host Disease (SR-aGvHD) Treatment | Biotech Hunter | Biotech Hunter