Status and phase
Conditions
Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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
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.
Primary purpose
Allocation
Interventional model
Masking
24 participants in 1 patient group
Loading...
Central trial contact
Qiubai Li, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal