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

Early Phase 1

Not yet recruiting

• Conditions: Systemic Lupus Erythematosus; Rheumatoid Arthritis; Dry Syndrome; Idiopathic Inflammatory Myopathies; Systemic Sclerosis
• Interventions: Biological: UTAA91 injection

• Registration Number: NCT06970951
• Lead Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.

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).

Detailed Description

Following the signing of the informed consent form, eligible subjects will receive an infusion of UTAA91 injection. Blood samples will be collected from the subjects before and after the infusion for pharmacokinetic, pharmacodynamic, immunogenicity, and safety assessments.

Aside from the baseline period, efficacy evaluations will be conducted periodically during the treatment phase after cell reinfusion until the occurrence of one of the following events, with the earliest event taking precedence: disease progression, initiation of new anti - disease treatment, death, intolerable toxicity, the investigator's decision, or the subject's voluntary withdrawal.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-06
• Study First Submitted QC: 2025-05-06
• Last Update Submitted: 2025-05-06
• Study First Posted: 2025-05-14
• Last Update Posted: 2025-05-14
• Study Start: 2025-05-18
• Primary Completion: 2026-06-30
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Adverse events	About 1 year	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).

Secondary Outcome Measures

Name	Time	Method
Disease remission rate	About 3 months	The disease remission/response/improvement rates at 28 days, 2 months, and 3 months after treatment with UTAA09 injection.
Cmax	About 1 year	Maximum concentration of UTAA91 injection amplified in peripheral blood after administration of the drug
Tmax	About 1 year	Time to reach maximum concentration in peripheral blood after administration of UTAA91 injection

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China