Refractory ANCA Associated Vasculitis and Lupus Nephritis Treated With BCMA-targeting CAR-
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 th
| Condition(s) | Lupus Nephritis, ANCA Associated Vasculitis |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 path |
| Who can participate | Inclusion Criteria: 1. Age ≥ 18 years old, not exceeding 70 years old (including 70 years old); 2. If the kidneys are involved, estimate the glomerular filtration rate (eGFR) to be ≥ 15 mL/minute/1.73 m2; 3. The following test values within 3 days before the collection of mononuclear cells meet the following standards: 1. Absolute lymphocyte count: ≥ 0.5 × 10 \^ 9/L \[The use of granulocyte colony-stimulating factor (G CSF) is allowed, but subjects are not allowed to receive this supportive treatment within 7 days before the screening period laboratory examination\]; 2. 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 |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | Lingli Dong |
| Locations | Wuhan, Hubei, China |
| Start date | 2024-02-05 |
| NCT ID | NCT06277427 |
| Official listing | https://clinicaltrials.gov/study/NCT06277427 |