CLBR001 + SWI019

**CLBR001 + SWI019** is an investigational switchable CAR-T cell therapy combination developed by Calibr-Skaggs Institute for Innovative Medicines in collaboration with AbbVie. It consists of CLBR001, autologous T cells engineered with a switchable chimeric antigen receptor (sCAR) featuring an alpha-PNE binding domain, and SWI019, an anti-CD19 monoclonal antibody that serves as a molecular switch. SWI019 binds to the CLBR001 binding domain to activate the CAR-T cells, enabling controlled targeting and lysis of CD19-positive B cells while allowing deactivation by withholding SWI019 to mitigate toxicities like cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Preclinical and early Phase 1 data demonstrate potent tumor elimination, robust engraftment, and improved safety with shorter adverse event durations compared to conventional CAR-T therapies. It has received FDA Fast Track designation for relapsed/refractory B-cell malignancies and is being evaluated in autoimmune diseases.[1][2][3][5][7][9]