UTAA91 injection for refractory rheumatoid arthritis

Clinical Study on the Treatment of Refractory Moderate - to - Severe Active Rheumatoid Arthritis With UTAA91 Injection

This trial will test whether injecting UTAA91 is safe for adults with moderate-to-severe rheumatoid arthritis that has not responded to standard treatments.

Quick facts

• Phase: Early Phase 1
• 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 (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07001956 on ClinicalTrials.gov

What this trial studies

This is an open-label, single-arm, single-center early-phase 1 trial enrolling adults with refractory moderate-to-severe active rheumatoid arthritis. Participants will receive UTAA91 injections and be monitored primarily for safety using clinical exams, laboratory tests, and adverse event reporting. The study is investigator-initiated and conducted at Union Hospital, Tongji Medical College in Wuhan, with exclusions for recent malignancy, active infections, severe cardiac disease, and pregnancy. Secondary observations will record tolerability and any preliminary signs of clinical activity.

Who should consider this trial

Good fit: Adults (≥18) with moderate-to-severe active rheumatoid arthritis unresponsive to standard treatments, adequate liver/kidney/cardiopulmonary function, no severe psychiatric disorder, and able to give informed consent.

Not a fit: Patients with recent malignancy within five years, positive viral or syphilis tests, severe cardiac or unstable systemic disease, active uncontrolled infections, CNS involvement, or who are pregnant or breastfeeding are unlikely to be eligible or benefit.

Why it matters

Potential benefit: If safe, UTAA91 could provide a new treatment option for patients with refractory moderate-to-severe RA who have exhausted standard therapies.

How similar studies have performed: UTAA91 appears to be an early-phase, novel intervention with limited prior clinical data specifically for this agent, although other injectable targeted therapies for refractory RA have shown mixed early promise.

Eligibility criteria

Inclusion Criteria:

* Aged ≥18 years (inclusive of the boundary value), with no restriction on gender.
* Expected survival time of at least 3 months.
* Subjects with refractory moderate - to - severe active rheumatoid arthritis who have failed standard treatment or lack effective therapeutic options.
* Meet the requirements for liver and kidney function, as well as cardiopulmonary function.
* Free from severe psychiatric disorders.
* Able to understand the trial and have 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.
* Subjects with positive results in virus/syphilis tests.
* Severe cardiac diseases or unstable systemic diseases.
* Active or uncontrollable infections requiring systemic treatment within 7 days before administration; evidence of central nervous system invasion at screening.
* 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 before screening.
* Subjects who participated in other clinical studies within 1 month before 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 Rheumatoid Arthritis