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

NCT06970951 | Not Yet Recruiting Early Phase 1

• 1 other identifier: PG-009-03
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Systemic Lupus Erythematosus; Rheumatoid Arthritis; Dry Syndrome; Idiopathic Inflammatory Myopathies; Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

• Adverse events

  The types, frequency, and severity of adverse events (AEs) and laboratory abnormalities (according to the Common Terminology Criteria for Adverse Events, NCI CTCAE 5.0).

  About 1 year

Secondary Outcomes (3)

• Cmax

  About 1 year

• Tmax

  About 1 year

• Disease remission rate

  About 3 months

Study Arms (1)

UTAA91 injection

EXPERIMENTAL

Infusion of UTAA91 injection in subjects screened after signing informed consent.

Biological: UTAA91 injection

Interventions

UTAA91 injection BIOLOGICAL

Infusion of UTAA91 injection in subjects screened after signing informed consent.

UTAA91 injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \. Presence of active or uncontrollable infections requiring systemic treatment.
• \. 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.
• \. Subjects who have received CAR - T therapy or other gene - modified cell therapies before screening.

Sponsors & Collaborators

• PersonGen BioTherapeutics (Suzhou) Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Arthritis, Rheumatoid; Myositis; Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases; Skin Diseases

Study Officials

• Jian Wu, Doctor

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Wu, Doctor

CONTACT

15358805676; njwujian@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: UTAA91 injection

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: May 18, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)