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

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPersonGen BioTherapeutics (Suzhou) Co., Ltd.

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • UTAA91 injection

Treatment groups

15 Participants
are divided into 1 treatment group