Tests UTAA91 injection in adults with returning autoimmune diseases
Tests UTAA91 injection for safety in adults with relapsed or refractory autoimmune diseases.
Plain-language title generated from the registry record
Registry title: Early Clinical Study of UTAA91 Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
Key facts
- Where
- Suzhou, ChinaSee the site
- Phase
- Early phase 1
Where in China
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- Trial code
- NCT06970951
- Record updated
- 14 May 2025
- Original description
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).Read full original descriptionShow less
A Single-Arm, Open-Label, Single-Center Investigator-Initiated Early-Stage Clinical Study for Relapsed/Refractory (R/R) Autoimmune Diseases
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).
Inclusion: Age ≥ 18 years (including the cut - off value), with no restrictions on gender; Expected survival time ≥ 3 months; Subjects with relapsed/refractory autoimmune diseases who have failed standard treatment or lack effective treatment options, including but not limited to rheumatoid arthritis, systemic sclerosis, systemic lupus erythematosus, idiopathic inflammatory myopathies, Sjögren's syndrome, connective tissue disease - related interstitial lung disease, immune thrombocytopenia, primary biliary cholangitis, etc; Liver and kidney functions and cardiopulmonary functions meet the requirements; No severe mental disorders; Able to understand this trial and have signed the informed consent form.
Exclusion: Subjects who have received CAR - T therapy or other gene - modified cell therapies before screening; Malignant tumors other than relapsed/refractory autoimmune diseases (R/R AID) within 5 years before screening; Presence of severe heart disease or unstable systemic diseases; Presence of active or uncontrollable infections requiring systemic treatment; Subjects with positive virus and/or syphilis tests; Pregnant or breastfeeding women, as well as female subjects who plan to become pregnant within 2 years after cell infusion or male subjects whose partners plan to become pregnant within 2 years after their cell infusion.