UTAA91 injection: Infusion of UTAA91 injection in subjects screened after signing informed consent.
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria
1. Age ≥ 18 years (including the cut - off value), with no restrictions on gender.
2. Expected survival time ≥ 3 months.
3. 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.
4. Liver and kidney functions and cardiopulmonary functions meet the requirements.
5. No severe mental disorders.
6. Able to understand this trial and have signed the informed consent form.
Exclusion Criteria
1. Malignant tumors other than relapsed/refractory autoimmune diseases (R/R AID) within 5 years before screening.
2. Subjects with positive virus and/or syphilis tests.
3. Presence of severe heart disease or unstable systemic diseases.
5\. Presence of active or uncontrollable infections requiring systemic treatment.
6\. 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.
7\. Subjects who have received CAR - T therapy or other gene - modified cell therapies before screening.
Primary outcome measure(s)
Adverse events — About 1 year The types, frequency, and severity of adverse events (AEs) and laboratory abnormalities (according to the Common Terminology Criteria for Adverse Events, NCI CTCAE 5.0).
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Soochow University
Suzhou
Jiangsu
More PersonGen BioTherapeutics (Suzhou) Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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