RecruitingEarly Phase 1NCT07000682

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

Clinical Study on the Treatment of Refractory Moderate-to-Severe Active Systemic Sclerosis With UTAA91 Injection

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Enrollment

24 participants

Start Date

May 30, 2025

Study Type

INTERVENTIONAL

Conditions

Systemic Sclerosis (SSc)

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria6

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.