NCT07001956RecruitingEarly phase 1
The Clinical Study on the Treatment of Refractory RA With UTAA91 Injection
Clinical Study on the Treatment of Refractory Moderate - to - Severe Active Rheumatoid Arthritis With UTAA91 Injection
Source: ClinicalTrials.gov · Last updated 18 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This clinical trial is designed as a single - arm, open - label, single - center, investigator - initiated early - phase clinical study. The primary objective is to evaluate the safety of UTAA91 injection in treating subjects with refractory moderate - to - severe active rheumatoid arthritis.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 25 May 2025
- Start date
- 30 May 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT07001956
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 24
- From 30 May 2025 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active or uncontrollable infections requiring systemic treatment within 7 days before administration; evidence of central nervous system invasion at screening.
- 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 illness
- A history of malignant tumors other than relapsed/refractory autoimmune diseases (R/R AID) within 5 years prior to screening.
- Severe cardiac diseases or unstable systemic diseases.
- Other conditions deemed unsuitable for enrollment by the investigator.
Other
- Subjects with positive results in virus/syphilis tests.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.