Safety and Tolerability of a Single Intravenous Infusion of BX-U001 in Refractory Rheumatoid Arthritis

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

December 1, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

February 20, 2027

Conditions
Rheumatoid Arthritis
Interventions
BIOLOGICAL

hUC-MSC suspension

Patients will be treated at dose of 0.75×10\^6 cells/kg of body weight (Cohort 1) or 1.5×10\^6 cells/kg of body weight (Cohort 2) via a single IV infusion using a blood transfusion kit.

BIOLOGICAL

Placebo

Placebo contains the same cell suspension as BX-U001 but without cells.

All Listed Sponsors
lead

Baylx Inc.

INDUSTRY