RecruitingEarly Phase 1NCT07001956

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

Clinical Study on the Treatment of Refractory Moderate - to - Severe Active Rheumatoid Arthritis With UTAA91 Injection

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Enrollment

24 participants

Start Date

May 30, 2025

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis (RA)

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria8

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.

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.