Not Yet RecruitingEarly Phase 1

Early Clinical Study of UTAA91 Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases

China15 participantsStarted 2025-05-18

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. Malignant tumors other than relapsed/refractory autoimmune diseases (R/R AID) within 5 years before screening.
✕. Subjects with positive virus and/or syphilis tests.
✕. Presence of severe heart disease or unstable systemic diseases.

What they're measuring

Adverse events

Timeframe: About 1 year

Trial details

NCT IDNCT06970951

SponsorPersonGen BioTherapeutics (Suzhou) Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Jian Wu, Doctor

15358805676 njwujian@163.com

View on ClinicalTrials.gov More Systemic Lupus Erythematosus trials