Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of refractory autoimmune diseases
Age 18-65 years old, regardless of gender, signed with informed consent (ICF).
Diagnosed as one of the following diseases: Systemic lupus erythematosus (SLE)；Sjogren's syndrome (SS) ; Systemic Scleroderma (SSc); Dermatomyositis (DM); Anti neutrophil cytoplasmic antibody associated vasculitis (ANCA-AAV).
For SLE patients, SLEDAI ≥ 8 points;
For SS patients, Sjogren's syndrome disease activity index(ESSDAI )≥ 14 points;
Previously received Chimeric Antigen Receptor T cell(CAR-T) therapy;
Suffering from severe diseases of the heart, liver, lungs, blood system, and endocrine system, the researcher has determined that the risk of participating in the trial is higher than the benefit;
Active or uncontrollable infections that require systemic treatment within the first week of screening;
Previously received hematopoietic stem cell transplantation or solid organ transplantation (excluding corneal and hair transplantation), or screened for acute graft-versus-host disease (GVHD) with grade 2 or above in the first two weeks;
Single group
JY231
GeneticInfusion of JY231 Injection by dose of 1-10×10\^6 TU/kg、 1-5×10\^7 TU/kg、5-10 ×10\^7 TU/kg Administration method: intravenous infusion、Splenic artery infusion、Lymph node infusion; Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion (PI evaluation is required)
Objective Response Rate
Metric/method of measurement: (2007)《Revised response criteria for malignant lymphoma》
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