FDA Grants Fast Track Status to Investigational Therapy CABA-201 for Lupus Treatment
CABA-201, an investigational therapy by Cabaletta Bio, Inc. has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) as a possible treatment for lupus and lupus nephritis (LN, lupus-related kidney disease). A CAR T-cell therapy, CABA-201 targets B cells (immune-system cells involved in the production of autoantibodies and lupus disease activity). CAR T-cells are genetically altered cells and T-cells are part of the immune system. To make CAR-T cells, scientists create or engineer new cells called chimeric antigen receptors (CARs), and then introduce T-cells into them.
The Phase 1 / 2 clinical trial of CABA-201 will involve six people with active LN, and six people with active lupus and without kidney disease. Each group’s experience will be monitored separately. CABA-201 is given as a one-time infusion (through the vein).
Continue to follow the Lupus Foundation of America for CABA-201 updates, as well as other lupus drug development news, and learn about medications used to treat lupus.
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