Status:
NOT_YET_RECRUITING
Early Clinical Study of UTAA91 Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
Lead Sponsor:
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Conditions:
Systemic Lupus Erythematosus
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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 injec...
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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 Criteria
- Malignant tumors other than relapsed/refractory autoimmune diseases (R/R AID) within 5 years before screening.
- Subjects with positive virus and/or syphilis tests.
- 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.
Exclusion
Key Trial Info
Start Date :
May 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06970951
Start Date
May 18 2025
End Date
April 30 2027
Last Update
May 14 2025
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000