Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT06982534
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06982534
Study Brief:
Protocol Section:
NCT06982534