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

NCT06982534 | Not Yet Recruiting Early Phase 1

• 1 other identifier: PG-010-9
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Sclerosis (SSc)

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

Biological: UTAA91 injection

Interventions

UTAA91 injection BIOLOGICAL

CAR-modified gamma delta T cells

UTAA91 injection

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Qiubai Li, MD

CONTACT

+86-13995671635; qiubaili@hust.edu.cn

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: After signing the informed consent form, eligible subjects will be infused with UTAA91 injection. Blood samples will be collected from the subjects before and after the infusion for the evaluation of pharmacokinetics, pharmacodynamics, immunogenicity, safety, etc.

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2040
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)