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

NCT07001956 | Recruiting Early Phase 1

• 1 other identifier: PG-011-9 (1)
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• Adverse events

  The types, frequency, and severity of adverse events (AEs) and laboratory abnormalities (according to the Common Terminology Criteria for Adverse Events, NCI CTCAE 5.0).

  About 1 year

Secondary Outcomes (3)

• Cmax

  About 1 year

• Tmax

  About 1 year

• Disease remission rate

  About 3 months

Study Arms (1)

UTAA91 injection

EXPERIMENTAL

Biological: UTAA91 injection

Interventions

UTAA91 injection 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.

UTAA91 injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Qiubai Li, MD

CONTACT

+8613995671635; qiubaili@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Department of Rheumatology and Immunology，Principal Investigator

Model Details: UTAA91 injection

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 3, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2040
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

CN (1)