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

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

Plain Language Summary

Simplified for easier understanding

This study is testing a new CAR-T cell therapy called UTAA91 for people with severe, treatment-resistant rheumatoid arthritis — a condition where the immune system attacks the joints — that has not improved with standard treatments. **You may be eligible if...** - You are 18 or older with moderate-to-severe rheumatoid arthritis that has not responded to standard treatments - Your liver, kidneys, and heart are in adequate condition for the therapy - You do not have serious psychiatric disorders - You are expected to live at least 3 months **You may NOT be eligible if...** - You have had another cancer in the past 5 years - You have active hepatitis B, hepatitis C, HIV, or syphilis - You have severe heart disease or an uncontrolled infection - You have received CAR-T therapy or gene-modified cell therapy before - You are pregnant, breastfeeding, or planning to become pregnant within 2 years of treatment - You have been in another clinical trial within the past month Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

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

Wuhan, Hubei, China

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NCT07001956


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