UTAA91 injection for refractory systemic sclerosis

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

This trial will test whether UTAA91 injections are safe and tolerable in adults with refractory moderate-to-severe systemic sclerosis.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07000682 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) with refractory moderate-to-severe active systemic sclerosis who have failed standard therapies, have expected survival ≥3 months, adequate organ function, and can provide informed consent are ideal candidates.

Not a fit: Patients with mild disease controlled by standard therapies, active or uncontrolled infections, recent malignancy, severe cardiac or unstable systemic disease, or those who are pregnant or breastfeeding are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, UTAA91 could offer a new treatment option for people with refractory moderate-to-severe systemic sclerosis who have few alternatives.

How similar studies have performed: Similar early-phase injections or biologic therapies for systemic sclerosis have shown limited and mixed results in prior small studies, so this approach remains exploratory.

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.

Where this trial is running

Wuhan, Hubei

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

Study contacts

• Study coordinator: Qiubai Li, MD

Conditions: Systemic Sclerosis