A Clinical Study Exploring the Safety, Efficacy and Cell Metabolic Dynamics of Universal CD19 / 20 Car-t Cell Injection in Moderate to Severe Refractory Systemic Lupus Erythematosus
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
This study is a single arm, open, exploratory dose escalation clinical study to evaluate the safety, efficacy, and cellular metabolic dynamics of ct1195e cells in patients with SLE.
Eligibility Criteria
Inclusion Criteria: * Voluntary signing of Informed Consent Form (ICF): I fully understand and am informed of this study, and I have signed the Informed Consent Form, expressing my willingness to follow and complete all research procedures; * When signing the ICF, the age should be between 18 and 65 years old (inclusive), with no gender restrictions; * No systemic active infection (such as infectious pneumonia, tuberculosis) within 2 weeks before screening; * Females with fertility (defined as all females who are physiologically capable of becoming pregnant) must agree to use highly effective contraception from at least 28 days before the start of self-cleaning to 1 year after CT1195E infusion, and absolutely prohibit egg donation within 1 year after receiving study treatment during the study period. Their male partners with fertility must agree to use effective barrier contraception from the start of self-cleaning to 1 year after CT1195E infusion, and should not donate semen or sperm