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

Clinical Study on the Treatment of Refractory Moderate-to-Severe Active Systemic Sclerosis With UTAA91 Injection

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Systemic Sclerosis (SSc)
• Intervention / Treatment: Biological: UTAA91 injection

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Qiubai Li, MD; Phone Number: +86-13995671635; Email: qiubaili@hust.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Qiubai Li, MD; Phone Number: +86-13995671635; Email: qiubaili@hust.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UTAA91 injection	Biological: UTAA91 injection; CAR-modified gamma delta T cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2040

Study Registration Dates

• First Submitted: May 13, 2025
• First Submitted That Met QC Criteria: May 13, 2025
• First Posted (Actual): May 21, 2025

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Connective Tissue Diseases; Skin Diseases; Sclerosis; Scleroderma, Systemic; Scleroderma, Diffuse
• Other Study ID Numbers: PG-010-9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No