Clinical Study on the Treatment of Systemic Sclerosis With UTAA91 Injection.

Launched by PERSONGEN BIOTHERAPEUTICS (SUZHOU) CO., LTD. · May 13, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called UTAA91 injection for people suffering from systemic sclerosis (SSc), a chronic disease that causes hardening and tightening of the skin and connective tissues. The main goal of the study is to see if this treatment is safe for patients who have moderate to severe forms of SSc that haven't responded to standard therapies. The trial will take place at one location 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 been diagnosed with moderate to severe systemic sclerosis that hasn't improved with other treatments. They must also be in generally good health with stable liver, kidney, and heart function. Additionally, individuals must not have severe mental health issues or active infections. Participants will need to understand the study and agree to take part by signing a consent form. It's important to note that pregnant or breastfeeding women and those who have received certain advanced therapies recently will not be eligible. If you qualify and choose to participate, you can expect to be closely monitored for safety while receiving the UTAA91 injection.

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.