Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
NCT Number: NCT06982547
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Early Phase 1
Wuhan, Hubei, 430000, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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).
Time frame: About 1 year
Maximum concentration of UTAA91 injection amplified in peripheral blood after administration of the drug
Time frame: About 1 year
Time to reach maximum concentration in peripheral blood after administration of UTAA91 injection
Time frame: About 3 months
The disease remission/response/improvement rates at 28 days, 2 months, and 3 months after treatment with UTAA91 injection.
Contact information is provided by the study sponsor or research team.
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Industry
Clinical Study on the Treatment of Refractory Moderate - to - Severe Active Rheumatoid Arthritis With UTAA91 Injection
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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