CELL LINE-BASED REDIRECTED T-CELL CYTOTOXICITY ASSAY

摘要

This disclosure provides a cell-based assay for testing the potency of multispecific binding molecules which specifically bind a T-cell antigen and a target antigen for redirected T-cell-mediated cellular cytotoxicity. The assay uses the TALL-104 T-cell line as effector cells, and provides a sensitive, specific, and reproducible method for ensuring that purity, activity, and stability of multispecific binding molecule batches can be measured for development, clinical trials, and commercial marketing.

主权项

1. A method of measuring the cytotoxic potential of a multispecific binding molecule comprising:
a. contacting the multispecific binding molecule with an immortalized cytotoxic T-cell (CTL) effector cell, wherein the CTL effector cell is a TALL-104 cell (ATCC CRL 11386), and wherein the multispecific binding molecule specifically binds the CTL effector cell via a T-cell (TC) antigen binding domain; b. contacting the multispecific binding molecule with a target cell, wherein the target cell expresses a target antigen, and wherein the multispecific binding molecule specifically binds to the target cell via a target antigen binding domain; and c. determining the extent of specific target cell death upon formation of an effector cell-multispecific binding molecule-target cell complex, thereby determining the cytotoxic potential of the multispecific binding molecule.