Systemic Sclerosis (SSc)
Conditions
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.
Interventions
BIOLOGICALUTAA91 injection
CAR-modified gamma delta T cells
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Cmax | About 1 year | Maximum concentration of UTAA91 injection amplified in peripheral blood after administration of the drug |
Countries
China
Contacts
Primary ContactQiubai Li, MD
Outcome results
None listed