Clinical Study on the Treatment of Refractory Rheumatoid Arthritis With UTAA91 Injection

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPersonGen BioTherapeutics (Suzhou) Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • UTAA91 injection

Treatment groups

24 Participants
are divided into 1 treatment group