The Clinical Study on the Treatment of SSc With UTAA91 Injection.

Launched by UNION HOSPITAL, TONGJI MEDICAL COLLEGE, HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY · May 24, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called UTAA91 injection for people with systemic sclerosis (SSc), a serious condition that affects the skin and other organs. The main goal of the study is to see if this injection is safe for individuals whose SSc has not improved with standard treatments. The trial will take place at a single center and will not be recruiting participants just yet.

To be eligible for this study, participants need to be at least 18 years old and have moderate to severe SSc that has not responded to other treatments. They should also have a life expectancy of at least three months and meet specific health requirements related to their liver, kidneys, and heart. People with certain serious health issues or infections, as well as pregnant or breastfeeding women, will not be allowed to join. If you or someone you know is interested, keep an eye out for the recruitment announcement for more details on how to participate!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged ≥18 years (inclusive of the boundary value), with no restriction on gender.
• • Expected survival time of ≥3 months. Refractory moderate - to - severe active systemic sclerosis that has failed standard treatment or lacks effective therapeutic options.
• • Meets the requirements for liver and kidney function, as well as cardiopulmonary function.
• • Free from severe psychiatric disorders. Able to understand the trial and has signed the informed consent form.
• Exclusion Criteria:
• • A history of malignant tumors other than relapsed/refractory autoimmune diseases (R/R AID) within 5 years prior to screening.
• • Positive results in virology/syphilis tests. Severe cardiac diseases or unstable systemic diseases. Presence of active or uncontrollable infections requiring systemic treatment, or evidence of central nervous system invasion.
• • Pregnant or breastfeeding women, female subjects planning 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.
• • Subjects who have received CAR - T therapy or other gene - modified cell therapies prior to screening.
• • Subjects who participated in other clinical studies within 1 month prior to screening.
• • Other conditions deemed unsuitable for enrollment by the investigator.