About this trial
Lupus nephritis (LN) and ANCA-associated vasculitis are severe autoimmune diseases, which may lead to the death of patients, particularly when they are refractory to the conventional therapeutic agents. Based on the current knowledge, the autoantibodies against self-antigens may exert important pathological roles in the pathogenesis of both LN and ANCA-associated vasculitis, of which the origins are primarily plasmablasts and plasma cells. BCMA is the molecule expressed on memory B cells, plasmablasts and plasma cells, and therefore is an ideal target for the elimination of potential pathogenic antibody secreting cells. Chimeric antigen receptor (CAR) T cells against BCMA may provide a novel therapeutic way for the refractory LN and ANCA-associated vasculitis patients to eliminate the pathogenic autoantibody-secreting cells. In this study, the safety and efficacy of a novel CAR-T cell therapy using PRG-1801 cells, are evaluated in patients with refractory LN and ANCA-associated vasculitis.
Eligibility criteria
Qualifiers
Age ≥ 18 years old, not exceeding 70 years old (including 70 years old);
If the kidneys are involved, estimate the glomerular filtration rate (eGFR) to be ≥ 15 mL/minute/1.73 m2;
Absolute lymphocyte count: ≥ 0.5 × 10 ^ 9/L [The use of granulocyte colony-stimulating factor (G CSF) is allowed, but subjects are not allowed to receive this supportive treatment within 7 days before the screening period laboratory examination];
Absolute neutrophil count: ≥ 1.0 × 10 ^ 9/L [The use of granulocyte colony-stimulating factor (G-CSF) is allowed, but subjects are not allowed to receive this supportive treatment within 7 days before the screening period laboratory examination];
Disqualifiers
Pregnant or lactating women;
If combined with alveolar hemorrhage, invasive pulmonary ventilation is required;
Refractory GPA and MPA: Combined with other autoimmune diseases involving multiple organ systems, such as EGPA, SLE, IgA vasculitis (Henoch Schönlein), rheumatoid arthritis, inflammatory myositis, anti-glomerular basement membrane disease, or cryoglobulinemia vasculitis;
Difficult to treat LN: severe extrarenal clinical manifestations such as lupus encephalopathy, pulmonary hemorrhage, lupus myocarditis, lupus enteritis, and lupus crisis; Other autoimmune diseases other than combined SLE, including dermatomyositis/polymyositis, mixed connective tissue disease, systemic sclerosis, rheumatoid arthritis, etc;
Trial design
Treatments tested in this trial
- PRG-1801 (CAR-T against BCMA)
Treatment groups
Sponsors and collaborators
Lingli Dong
Lead sponsor
Tongji Hospital
Sponsor institution
Shenzhen Pregene Biopharma Co., Ltd.
Collaborator