Early Clinical Study of UTAA91 Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- Study ID
- NCT06970951
- Phase
- EARLY_PHASE1
- Status
- Not Yet Recruiting
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Conditions
- Dry Syndrome
- Idiopathic Inflammatory Myopathies
- Rheumatoid Arthritis
- Systemic Lupus Erythematosus
- Systemic Sclerosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- UTAA91 injection — BIOLOGICALInfusion of UTAA91 injection in subjects screened after signing informed consent.
Study Details
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 relapsed/refractory autoimmune inflammatory diseases (AID).
Key Dates
- First listed
- May 14, 2025
- Start date
- May 18, 2025
- Status verified
- May 2025
- Primary completion
- Jun 30, 2026
- Completion
- Apr 30, 2027
Study Design
- Enrollment
- 15 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: UTAA91 injectionInfusion of UTAA91 injection in subjects screened after signing informed consent.
Primary Outcome Measure
Adverse events [ Time Frame: About 1 year ]
Central Contacts
- Jian Wu, Doctor15358805676
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