UTAA91 injection for refractory systemic sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, open-label, single-center early-phase study administering UTAA91 injections to adults with refractory moderate-to-severe active systemic sclerosis who have failed standard treatments. The primary focus is safety and tolerability, with participants screened for adequate liver, kidney, and cardiopulmonary function and monitored for adverse events. Key exclusions include recent malignancy, positive viral or syphilis tests, active or uncontrolled infections, severe cardiac disease, and pregnancy or breastfeeding. Safety findings will determine whether further clinical development of UTAA91 in systemic sclerosis is warranted.

Why it matters

Who can join: the full rules

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.

Where it's running

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Qiubai Li, MD
• Email: qiubaili@hust.edu.cn
• Phone: +8613995671635

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.