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The Clinical Study on the Treatment of Refractory RA With UTAA91 Injection

RecruitingEARLY Phase 1Ages 18 Years - anyAllUnion Hospital, Tongji Medical College, Huazhong โ€ฆ
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Aged โ‰ฅ18 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.
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What it tests

  • UTAA91 injection
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Where

1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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