A Phase 1, Open-Label, Multicenter Study of KYV-101-001, an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Lupus Nephritis
Apheresis (collection of white blood cells) followed by lymphodepletion (medications to weaken, temporarily, your immune system so that the CAR T cells can grow and work in the body, followed by single infusion of KYV-101 (the CAR T cells made specifically for your body)
Adult
* age of 18 or older * lupus nephritis that has not responded to other therapies
* clinical diagnosis of SLE * active, biopsy-proven, proliferative lupus nephritis class III or IV * inadequate response (urine protein equal to or greater than 1.5 g/24 hrs after at least 6 months of treatment with 2 or more conventional therapies * up to date on vaccinations, including against COVID-19 * not pregnant
Treatment
Outpatient CTRC
Renal Research Center
University of Colorado Hospital
Amber Podoll, MD
Protocol Number: 22-1850
More information available at ClinicalTrials.gov: NCT05938725
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