Sloan-Kettering puts CAR therapy trials on hold

Memorial Sloan-Kettering Cancer Center said a routine review of adverse events prompted it to halt enrollment in trials of autologous T cells with a chimeric antigen receptor (CAR) specific to the CD19 antigen. The trials were put on hold on March 7, but first disclosed this weekend at the American Association for Cancer Research meeting during a presentation of updated data from one of the halted trials. A spokesperson for Juno Therapeutics Inc. (Seattle, Wash.) said there were 10 deaths, including two treatment-related deaths, out of 22 patients in a Phase I trial to treat relapsed B cell acute lymphoblastic leukemia (ALL). Juno has rights from Sloan-Kettering to the technology used to create the T cells.

The other halted trials are: a Phase I trial to treat relapsed and refractory B cell non-Hodgkin's lymphoma (NHL); a Phase I trial to treat chronic lymphocytic leukemia (CLL) following chemotherapy; a Phase I trial to treat relapsed B cell ALL in patients younger than 26 years of age; and a Phase I/IIa trial to treat relapsed or refractory CLL or indolent B cell lymphoma. Sloan-Kettering said it is working with FDA to change the enrollment criteria for the halted trials. The center and Juno declined to disclose further details, including the cause of the treatment-related deaths. ...