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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

Primary Objective

To test CAR T cell therapy (a type of therapy made from one's own immune cells) for refractory lupus nephritis

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Description

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)

Details
Age
Adult
Eligibility
* 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
Locations

Outpatient CTRC
Renal Research Center
University of Colorado Hospital

Principal Investigator
Photograph of Amber Podoll

Amber Podoll

Study ID

Protocol Number: 22-1850

More information available at ClinicalTrials.gov: NCT05938725

Categories

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