Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
Location status: Recruiting
NCT Number: NCT07000682
This clinical trial is designed as a single-arm, open-label, single-center investigator-initiated early-phase study, with the primary objective of evaluating the safety of UTAA91 injection in subjects with refractory moderate-to-severe active systemic sclerosis.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Early Phase 1
Wuhan, Hubei, 430000, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Expected survival time of ≥3 months. Refractory moderate - to - severe active systemic sclerosis that has failed standard treatment or lacks effective therapeutic options.
Meets the requirements for liver and kidney function, as well as cardiopulmonary function.
Free from severe psychiatric disorders. Able to understand the trial and has signed the informed consent form.
Exclusion criteria
Positive results in virology/syphilis tests. Severe cardiac diseases or unstable systemic diseases. Presence of active or uncontrollable infections requiring systemic treatment, or evidence of central nervous system invasion.
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 prior to screening.
Subjects who participated in other clinical studies within 1 month prior to screening.
Other conditions deemed unsuitable for enrollment by the investigator.
CAR-modified gamma delta T cells
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 UTAA09 injection.
Contact information is provided by the study sponsor or research team.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Other
Clinical Study on the Treatment of Refractory Moderate-to-Severe Active Systemic Sclerosis 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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