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

NCT ID: NCT07001956

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-30
• Study Completion Date: 2040-06-30

Brief 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.

Conditions

Rheumatoid Arthritis (RA)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UTAA91 injection

Group Type: EXPERIMENTAL

UTAA91 injection

Intervention Type: BIOLOGICAL

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.

Interventions

UTAA91 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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Qiubai Li

Director, Head of Department of Rheumatology and Immunology，Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qiubai Li, MD

Role: CONTACT

qiubaili@hust.edu.cn

+8613995671635

Facility Contacts

Qiubai Li, MD

Role: primary

qiubaili@hust.edu.cn

+8613995671635

Other Identifiers

PG-011-9 (1)

Identifier Type: -

Identifier Source: org_study_id