This is an exploratory trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of a single dose of IMPT-514, an autologous, anti-CD19/CD20 CAR T therapy, administered as an intravenous (IV) infusion, in participants with B cell driven autoimmune diseases, including active, refractory Systemic Lupus Erythematosus (SLE), ANCA Associated Vasculitis (AAV), and Idiopathic Inflammatory Myopathy (IIM).
This study will explore the safety of IMPT-514 and will include up to two dose levels, with up to 12 total expected dosed participants for each disease group of SLE, AAV, and IIM. IMPT-514 treatment consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide. Individual participants will remain in the active post-treatment period for approximately 2 year from IMPT-415 administration.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
The Affiliated Hospital Of Xuzhou Medical University
Xuzhou, Jiangsu, China
Zhongshan Hospital Fudan University.
Shanghai, Shanghai Municipality, China
Incidence of dose limiting toxicities (DLTs), serious adverse events (SAE) and treatment-emergent adverse events (TEAEs).
Time frame: 28 days from cell infusion
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