Rheumatoid Arthritis (RA)
Conditions
Brief summary
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.
Interventions
BIOLOGICALUTAA91 injection
After signing the informed consent form, eligible subjects will receive an infusion of UTAA91 injection. Blood samples will be collected from the subjects before and after the infusion for the evaluation of pharmacokinetics, pharmacodynamics, immunogenicity, and safety.
Sponsors
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
UTAA91 injection
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | About 1 year | The types, frequency, and severity of adverse events (AEs) and laboratory abnormalities (according to the Common Terminology Criteria for Adverse Events, NCI CTCAE 5.0). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | About 1 year | Maximum concentration of UTAA91 injection amplified in peripheral blood after administration of the drug |
| Tmax | About 1 year | Time to reach maximum concentration in peripheral blood after administration of UTAA91 injection |
| Disease remission rate | About 3 months | The disease remission/response/improvement rates at 28 days, 2 months, and 3 months after treatment with UTAA91 injection. |
Countries
China
Contacts
Primary ContactQiubai Li, MD
Outcome results
None listed