NCT06982534Not yet recruitingEarly phase 1
Clinical Study on the Treatment of Systemic Sclerosis With UTAA91 Injection.
Clinical Study on the Treatment of Refractory Moderate-to-Severe Active Systemic Sclerosis With UTAA91 Injection
Source: ClinicalTrials.gov · Last updated 21 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 13 May 2025
- Start date
- Jun 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT06982534
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 24
- From Jun 2025 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 illness
- A history of malignant tumors other than relapsed/refractory autoimmune diseases (R/R AID) within 5 years prior to screening.
- Severe cardiac diseases or unstable systemic diseases.
- Presence of active or uncontrollable infections requiring systemic treatment, or evidence of central nervous system invasion.
- Other conditions deemed unsuitable for enrollment by the investigator.
Other
- Positive results in virology/syphilis tests.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.