Nkarta Says FDA Clears IND Application For NKX019 To Treat Lupus Nephritis

(RTTNews) - Biopharmaceutical company Nkarta, Inc. (NKTX) announced Tuesday the clearance of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) to evaluate NKX019, its allogeneic, CD19-directed CAR NK cell therapy candidate, for the treatment of lupus nephritis.

The multi-center, open label, dose escalation clinical trial will assess the safety and clinical activity of NKX019 in patients with refractory LN.

Patients will receive a three-dose cycle of NKX019 at 1 billion or 1.5 billion cells per dose on Days 0, 7 and 14 following lymphodepletion (LD) with single agent cyclophosphamide (cy), an agent with an established safety profile in SLE and LN.

The study is designed to enroll up to 12 patients, with the first patient expected to be enrolled in the first half of 2024.