Tests UTAA91 injection safety in adults with systemic sclerosis
Tests UTAA91 injection's safety in adults with hard-to-treat systemic sclerosis.
Plain-language title generated from the registry record
Registry title: The Clinical Study on the Treatment of SSc With UTAA91 Injection.
Key facts
- Where
- Wuhan, ChinaSee the site
- Phase
- Early phase 1
Where in China
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Trial code
- NCT07000682
- Record updated
- 18 July 2025
- Original description
This clinical trial is designed as a single-arm, open-label, single-center investigator-initiated early-phase study, with the primary objective of evaluating the safety of UTAA91 injection in subjects with refractory moderate-to-severe active systemic sclerosis.Read full original descriptionShow less
Clinical Study on the Treatment of Refractory Moderate-to-Severe Active Systemic Sclerosis With UTAA91 Injection
This clinical trial is designed as a single-arm, open-label, single-center investigator-initiated early-phase study, with the primary objective of evaluating the safety of UTAA91 injection in subjects with refractory moderate-to-severe active systemic sclerosis.
Inclusion: 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: 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.