Clinical Study on the Treatment of Systemic Sclerosis With UTAA91 Injection.

Early Phase 1

Not yet recruiting

• Conditions: Systemic Sclerosis (SSc)
• Interventions: Biological: UTAA91 injection

• Registration Number: NCT06982534
• 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 study, with the primary objective of evaluating the safety of UTAA91 injection in subjects with refractory moderate-to-severe active systemic sclerosis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-13
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21
• Study Start: 2025-06
• Primary Completion: 2027-12
• Study Completion: 2040-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Aged ≥18 years (inclusive of the boundary value), with no restriction on gender.
• Expected survival time of ≥3 months.
• Refractory moderate - to - severe active systemic sclerosis that has failed standard treatment or lacks effective therapeutic options.
• Meets the requirements for liver and kidney function, as well as cardiopulmonary function.
• Free from severe psychiatric disorders.
• Able to understand the trial and has signed the informed consent form.

Exclusion Criteria

• A history of malignant tumors other than relapsed/refractory autoimmune diseases (R/R AID) within 5 years prior to screening.
• Positive results in virology/syphilis tests.
• Severe cardiac diseases or unstable systemic diseases.
• Presence of active or uncontrollable infections requiring systemic treatment, or evidence of central nervous system invasion.
• Pregnant or breastfeeding women, female subjects planning 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 prior to screening.
• Subjects who participated in other clinical studies within 1 month prior to screening.
• Other conditions deemed unsuitable for enrollment by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
UTAA91 injection	UTAA91 injection	-

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
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
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.

Trial Locations

Locations (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China