A Clinical Study of YTS109 Cell in R/R Autoimmune Diseases (NCT06978647) | Clinical Trial Compass
RecruitingPhase 1
A Clinical Study of YTS109 Cell in R/R Autoimmune Diseases
China12 participantsStarted 2025-05-19
Plain-language summary
This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), etc. Aproximately 6-12 patients aged 18-65 will receive a single infusion of YTS109 cells (1.5×10⁶ cells/kg). The main purpose of exploratory clinical research is to explore the efficacy and safety of YTS109 cell and the lymphodepletion regimen. The primary endpoint is observations of types, severity, and frequency of adverse events (AEs) and efficacy assessment. This single-arm, open-label trial will enroll patients across Chinese People's Liberation Army (PLA) General Hospital.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Age ranges from 18 to 65 years old (including threshold), regardless of gender.
✓. Detection of positive CD19 expression on peripheral blood B cells by flow cytometry.
✓. Cardiovascular: Hemodynamic stability. 4. Fertile females or males with partners of childbearing age must use medically approved contraception or abstain during and ≥12 months post- treatment. Negative serum HCG test (within 7 days pre-enrollment) for fertile females; non-lactating.
Exclusion criteria
✕
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events
Timeframe: The efficacy endpoint evaluation for 2, 4, 8, 12 weeks, AEs observation will be follow-up for 24 weeks. The observation period is extended to 52 weeks.
. Individuals with a severe history of drug allergies or those with an allergic constitution;
✕. Individuals with existing or suspected uncontrolled or treatable fungal, bacterial, viral, or other infections;
✕. Subjects with central nervous system diseases (excluding those with a history of epilepsy, psychiatric disorders, organic brain disease syndromes, cerebrovascular accidents, encephalitis, or central nervous system vasculitis resulting from the underlying disease);
✕. Subjects whose cardiac function cannot tolerate the study interventions;
✕. Subjects with congenital immunoglobulin deficiencies;
✕. Subjects with a history of malignant tumors within the past five years;
✕. Subjects with end-stage renal failure;
✕. Subjects who are positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titers exceeding the upper limit of detection; subjects who are positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; subjects who are positive for human immunodeficiency virus (HIV) antibody; and subjects who are positive for syphilis testing;