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

Recruiting now · Early Phase 1

Conditions studied: Systemic Sclerosis (SSc)

In brief

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.

Key facts

Study ID

NCT07000682

Run by

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

People needed

24

Starts

2025-05-30

Expected to finish

2040-01-01

Last updated by the study team

2025-07-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)

Full record on ClinicalTrials.gov

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