The Clinical Study on the Treatment of Refractory RA With UTAA91 Injection
Recruiting · NCT07001956 · Interventional (participants receive a specific treatment) · Lead sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
View the official record on ClinicalTrials.gov →Interventions studied
UTAA91 injection
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology - Wuhan, Hubei, China