FDA Fast Tracks Potential CAR T-Cell Therapy for Lupus

The cellular therapy depletes CD19-positive B cells with the goal of 'resetting' the immune system to achieve durable remission.

The FDA cleared Cabaletta to begin a phase 1/2 clinical trial of CABA-201, the statement says, which will be the first trial accessing Cabaletta's Chimeric Antigen Receptor T cells for Autoimmunity approach. CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, is designed to target and deplete CD19-positive B cells,"enabling an 'immune system reset' with durable remission in patients with SLE," according to the press release.

This upcoming open-label study will enroll two cohorts containing six patients each. One cohort will be patients with SLE and active LN, and the other will be patients with SLE without renal involvement. The therapy is designed as a one-time infusion and will be administered at a dose of 1.

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