Status:
NOT_YET_RECRUITING
Clinical Study on the Treatment of Systemic Sclerosis With UTAA91 Injection.
Lead Sponsor:
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Conditions:
Systemic Sclerosis (SSc)
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2040
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06982534
Start Date
June 1 2025
End Date
January 1 2040
Last Update
May 21 2025
Active Locations (1)
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1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000