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NCT Number: NCT06982534

Clinical Study on the Treatment of Systemic Sclerosis With UTAA91 Injection.

This clinical trial is designed as a single-arm, open-label, single-center investigator-initiated early-phase study, with the primary objective of evaluating the safety of UTAA91 injection in subjects with refractory moderate-to-severe active systemic sclerosis.

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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]

+86-13995671635

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 ≥3 months.
  • Refractory moderate - to - severe active systemic sclerosis that has failed standard treatment or lacks effective therapeutic options.
  • Meets the requirements for liver and kidney function, as well as cardiopulmonary function.
  • Free from severe psychiatric disorders.
  • Able to understand the trial and has 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.
  • Positive results in virology/syphilis tests.
  • Severe cardiac diseases or unstable systemic diseases.
  • Presence of active or uncontrollable infections requiring systemic treatment, or evidence of central nervous system invasion.
  • 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 prior to screening.
  • Subjects who participated in other clinical studies within 1 month prior to screening.
  • Other conditions deemed unsuitable for enrollment by the investigator.

Treatment and study plan

UTAA91 injection

Biological

CAR-modified gamma delta T cells

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 UTAA09 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 Systemic Sclerosis 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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