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Recruiting Early Phase 1

The Clinical Study on the Treatment of SSc With UTAA91 Injection.

NCT07000682 · tracked via the Priya Life Science China tracker
Phase
Early Phase 1
Started
2025-05-30
Last updated
2025-07-18

Condition(s) studied

Systemic Sclerosis (SSc)

Investigational drug(s) / intervention(s)

UTAA91 injection →

UTAA91 injection: CAR-modified gamma delta T cells

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Adverse events — 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).

Trial sites (1)

FacilityCityRegionStatus
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07000682 on ClinicalTrials.gov ↗ ← All trials in China