Trials / Not Yet Recruiting
Not Yet RecruitingNCT06970951
Early Clinical Study of UTAA91 Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
A Single-Arm, Open-Label, Single-Center Investigator-Initiated Early-Stage Clinical Study for Relapsed/Refractory (R/R) Autoimmune Diseases
- Status
- Not Yet Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 relapsed/refractory autoimmune inflammatory diseases (AID).
Detailed description
Following the signing of 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 pharmacokinetic, pharmacodynamic, immunogenicity, and safety assessments. Aside from the baseline period, efficacy evaluations will be conducted periodically during the treatment phase after cell reinfusion until the occurrence of one of the following events, with the earliest event taking precedence: disease progression, initiation of new anti - disease treatment, death, intolerable toxicity, the investigator's decision, or the subject's voluntary withdrawal.
Conditions
- Systemic Lupus Erythematosus
- Rheumatoid Arthritis
- Dry Syndrome
- Idiopathic Inflammatory Myopathies
- Systemic Sclerosis
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | UTAA91 injection | Infusion of UTAA91 injection in subjects screened after signing informed consent. |
Timeline
- Start date
- 2025-05-18
- Primary completion
- 2026-06-30
- Completion
- 2027-04-30
- First posted
- 2025-05-14
- Last updated
- 2025-05-14
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06970951. Inclusion in this directory is not an endorsement.