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NCT Number: NCT06982547

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

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

Wuhan, Hubei, 430000, China

Location contact

Qiubai Li, MD

CONTACT

[email protected]

+8613995671635

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Adverse events

    Time frame: About 1 year

    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).

Secondary outcomes

  1. Cmax

    Time frame: About 1 year

    Maximum concentration of UTAA91 injection amplified in peripheral blood after administration of the drug

  2. Tmax

    Time frame: About 1 year

    Time to reach maximum concentration in peripheral blood after administration of UTAA91 injection

  3. Disease remission rate

    Time frame: About 3 months

    The disease remission/response/improvement rates at 28 days, 2 months, and 3 months after treatment with UTAA91 injection.

Study contacts

Contact information is provided by the study sponsor or research team.

Qiubai Li, MD

CONTACT

[email protected]

+86-13995671635

Sponsors and collaborators

Lead sponsor

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2040
First posted
May 21, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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