This is a phase 1, open-label, non-randomized study enrolling pediatric and young adult research participants with treatment-refractory Systemic Lupus Erythematosus (SLE), to examine the safety, feasibility, and efficacy of administering T cell products derived from peripheral blood mononuclear cells (PBMC) that have been genetically modified to express CD19 specific chimeric antigen receptor (CAR) A child or young adult meeting all eligibility criteria and meeting none of the exclusion criteria will have their T cells collected. The T cells will then be bioengineered into a CAR T cell that targets circulating and tissue residing B cells.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Single infusion of SCRI-CAR19v3
Seattle Children's Hospital
Seattle, Washington, United States
RECRUITINGIncidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The investigators will assess and described the type, frequency, severity, and duration of adverse events associated with the CAR T cell product.
Time frame: 28 days post-infusion
Rate of SCRI-CAR19v3 Manufacturing Success
We will measure the number of successfully manufactured SCRI-CAR19v3 products.
Time frame: 28 days
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