Clinical Study on the Treatment of Refractory Rheumatoid Arthritis With UTAA91 Injection
NCT06982547 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2025-05-21
Summary
This clinical trial is designed as a single - arm, open - label, single - center, investigator - initiated early - phase clinical study. The primary objective is to evaluate the safety of UTAA91 injection in treating subjects with refractory moderate - to - severe active rheumatoid arthritis.
Conditions
- Rheumatoid Arthritis (RA)
Interventions
- BIOLOGICAL
-
UTAA91 injection
After signing the informed consent form, eligible subjects will receive an infusion of UTAA91 injection. Blood samples will be collected from the subjects before and after the infusion for the evaluation of pharmacokinetics, pharmacodynamics, immunogenicity, and safety.
Sponsors & Collaborators
-
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-30
- Primary Completion
- 2027-12-31
- Completion
- 2040-06-30
Countries
- China
Study Locations
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