Early Clinical Study of UTAA91 Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases

Launched by PERSONGEN BIOTHERAPEUTICS (SUZHOU) CO., LTD. · May 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called UTAA91 injection for patients with certain autoimmune diseases that have not responded to standard treatments. These diseases include conditions like rheumatoid arthritis, systemic lupus erythematosus, and systemic sclerosis. The main goal of the trial is to determine if this injection is safe for patients who are experiencing a relapse or have not found effective treatments for their illnesses.

To participate in the trial, you must be at least 18 years old and have a serious autoimmune disease that hasn't responded to other treatments. It's important that your overall health is stable, with functioning liver, kidneys, and heart. Unfortunately, people with certain serious conditions, active infections, or who have had specific types of cancer recently cannot join. If you qualify and decide to participate, you will receive the UTAA91 injection and be monitored closely for any side effects or changes in your condition. This study is currently not recruiting, but it aims to provide valuable information for developing future treatments for autoimmune diseases.

Gender

ALL

Eligibility criteria

• • 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.