Tests UTAA91 injection for hard-to-treat rheumatoid arthritis
Tests UTAA91 injection, a biological drug, for safety in adults with active rheumatoid arthritis.
Plain-language title generated from the registry record
Registry title: Clinical Study on the Treatment of Refractory Rheumatoid Arthritis With UTAA91 Injection
Key facts
- Where
- Wuhan, ChinaSee the site
- Phase
- Early phase 1
Where in China
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- Trial code
- NCT06982547
- Record updated
- 21 May 2025
- Original description
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.Read full original descriptionShow less
Clinical Study on the Treatment of Refractory Moderate - to - Severe Active Rheumatoid Arthritis With UTAA91 Injection
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.
Inclusion: 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: 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; 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; 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.