The Clinical Study on the Treatment of SSc With UTAA91 Injection.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: UTAA91 injection.
- Who it may be relevant to
- Registry conditions: Systemic Sclerosis (SSc). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Study on the Treatment of Refractory Moderate-to-Severe Active Systemic Sclerosis With UTAA91 Injection
Overview
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.
Interventions
- Biological UTAA91 injection
CAR-modified gamma delta T cells
Primary outcome measures
- Adverse events [Time frame: About 1 year]
Secondary outcome measures (3)
- Cmax [Time frame: About 1 year]
- Tmax [Time frame: About 1 year]
- Disease remission rate [Time frame: About 3 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
Identifiers
NCT: NCT07000682 · PG-010-9 (1)