Tests UTAA91 injection in adults with returning autoimmune diseases
Tests UTAA91 injection for safety in adults with relapsed or refractory autoimmune diseases.
Plain-language title generated from the registry record
Registry title: Early Clinical Study of UTAA91 Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
Key facts
- Where
- Suzhou, ChinaSee the site
- Phase
- Early phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose autoimmune disease has come back or has not responded to standard treatment, to test the safety of UTAA91 injection.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Autoimmune disease that has relapsed or not responded, after failed standard treatment or with no effective treatment options. Examples: 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.
- Earlier treatment
- Standard treatment must have failed or not be available. People who had CAR-T therapy or other gene-modified cell therapy before screening cannot join.
Main reasons for not taking part
- Another malignant tumor within 5 years before screening
- Positive virus and/or syphilis tests
- Severe heart disease or unstable systemic diseases
- Active or uncontrollable infection needing systemic treatment
- Pregnant or breastfeeding women, or those planning pregnancy within 2 years after cell infusion
Read by machine on 12 November 2026.
Where in China
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaContact: Jian Wu, DoctorNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- Trial code
- NCT06970951
- Record updated
- 14 May 2025
- Original description
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).Read full original descriptionShow less
A Single-Arm, Open-Label, Single-Center Investigator-Initiated Early-Stage Clinical Study for Relapsed/Refractory (R/R) Autoimmune Diseases
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).
Inclusion: 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.
Exclusion: Subjects who have received CAR - T therapy or other gene - modified cell therapies before screening; Malignant tumors other than relapsed/refractory autoimmune diseases (R/R AID) within 5 years before screening; Presence of severe heart disease or unstable systemic diseases; Presence of active or uncontrollable infections requiring systemic treatment; Subjects with positive virus and/or syphilis tests; 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.