This is a single arm, open-label, dose escalation and expansion study to evaluate the safety, tolerability and preliminary efficacy of autologous chimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA(BZE2204) in patients with relapsed or refractory active autoimmune diseases, including idiopathic inflammatory myopathies(IIM), immune thrombocytopenia(ITP), systemic lupus erythematosus(SLE).
Males or females, aged 18-70 years old
Bone marrow reservation: absolute neutrophil count (ANC) ≥1 ×10^9/L; absolute lymphocyte count (ALC)≥ 0.5 ×10^9/L; hemoglobulin ≥80 g/L; platelets ≥50 ×10^9/L(except for ITP);
Hepatic function: i: Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 5 upper limit of normal(ULN) (except for elevations are evaluated to be related to autoimmune disease by investigators)and ii: total bilirubin ≤ 2 ULN, (except for Gilbert's syndrome patients, those with total bilirubin ≤ 3 ULN and direct bilirubin ≤ 1.5 ULN can be enrolled).
Renal function: serum creatinine ≤ 1.5 ULN , or estimated glomerular filtration rate(eGFR) ≥ 60 mL/min/1.73m2 [eGFR=186×age^-0.203×SCr^-1.154（mg/dl）,female×0.742]
A history of severe hypersensitivity or allergic reactions, or contraindications or hypersensitivity to any component of the investigational drug
Presence of any serious heart diseases defined in the protocol
A medical history of severe central nervous system or symptoms within 6 months
Any concurrent malignancy or a history of malignancy with exceptions indicated in the protocol
Single group
CD19/CD22/BCMA CAR-T cells(BZE2204)
Biological/VaccineSubjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of BZE2204 CAR T cells. On day0 subjects will receive a single dose BZE2204 CAR T cells by intravenous (IV) injection.
The frequency and severity of adverse events(AE) and serious adverse events(SAE)
The frequency of dose-limiting toxicity(DLT)
Chimeric antigen receptor T cell (CAR-T) levels in peripheral blood at each time point.
Chimeric antigen receptor transgene levels in peripheral blood at each time point
Cytokines levels of IL-2(interleukin), IL-4, IL-6,IL-8, IL-10, IL-12p70, IL-13, IL-1β, TNF-a, IFN-r in peripheral blood at each time point.
B cell levels in peripheral blood at each time point
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