The Clinical Study on the Treatment of SSc With UTAA91 Injection.

NCT ID: NCT07000682

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-30
• Study Completion Date: 2040-01-31

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UTAA91 injection

Group Type: EXPERIMENTAL

UTAA91 injection

Intervention Type: BIOLOGICAL

CAR-modified gamma delta T cells

Interventions

UTAA91 injection

CAR-modified gamma delta T cells

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Qiubai Li

Director, Head of Department of Rheumatology and Immunology, Principal Investigator, Professor, Wuhan Union Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qiubai Li, MD

Role: CONTACT

qiubaili@hust.edu.cn

+8613995671635

Facility Contacts

Qiubai Li, MD

Role: primary

qiubaili@hust.edu.cn

+8613995671635

Other Identifiers

PG-010-9 (1)

Identifier Type: -

Identifier Source: org_study_id