NCT06970951Not yet recruitingEarly phase 1
Early Clinical Study of UTAA91 Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
A Single-Arm, Open-Label, Single-Center Investigator-Initiated Early-Stage Clinical Study for Relapsed/Refractory (R/R) Autoimmune Diseases
Source: ClinicalTrials.gov · Last updated 14 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 clinical study. The primary objective is to evaluate the safety of UTAA91 injection in treating subjects with relapsed/refractory autoimmune inflammatory diseases (AID).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 6 May 2025
- Start date
- 18 May 2025
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- NCT number
- NCT06970951
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 15
- From 18 May 2025 to the primary completion date, 30 Jun 2026
- 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
- Presence of severe heart disease or unstable systemic diseases.
- 5\. Presence of active or uncontrollable infections requiring systemic treatment.
- 6\. Pregnant or breastfeeding women, as well as female subjects who plan 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.
- 7\. Subjects who have received CAR - T therapy or other gene - modified cell therapies before screening.
Other illness
- Malignant tumors other than relapsed/refractory autoimmune diseases (R/R AID) within 5 years before screening.
Other
- Subjects with positive virus and/or syphilis tests.
Who the study is looking for
- Age ≥ 18 years (including the cut - off value), with no restrictions on gender.
- Expected survival time ≥ 3 months.
- Subjects with relapsed/refractory autoimmune diseases who have failed standard treatment or lack effective treatment options, including but not limited to rheumatoid arthritis, systemic sclerosis, systemic lupus erythematosus, idiopathic inflammatory myopathies, Sjögren's syndrome, connective tissue disease - related interstitial lung disease, immune thrombocytopenia, primary biliary cholangitis, etc.
- Liver and kidney functions and cardiopulmonary functions meet the requirements.
- No severe mental disorders.
- Able to understand this trial and have 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 |
|---|---|---|---|
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.