20 year old man died after leukaemia cell was accidently mixed into CAR T therapy

pharmafile | October 2, 2018 | News story | Manufacturing and Production |  CAR T, CAR-T, Cancer, Kymriah, Novartis, leukaemia, oncology 

A 20 year old man died after a single leukaemia cell accidentally ended up in a batch of cells that were being manufactured into a CAR-T cell therapy, according to researchers at the University of Pennsylvania.

The mistake, which brought about a fatal relapse in the 20 year old man, was reported in the journal Nature Medicine.

The patient was entered into an early stage trial of CTL019, which was eventually licensed to Novartis and sold under the brand name Kymriah.  

Dr Marco Ruella who led the trial said the case was “exceptionally rare” as he noted that the findings were disclosed to the US FDA prior to the treatment’s approval.

However the authors suggested that better manufacturing technologies were needed “that can purge residual contaminating tumor cells from engineered T cells.”

Novartis also noted that they use a different manufacturing process to the one used by the University of Pennsylvania.

The Swiss multinational commented in a statement: “We are not aware of any cases of this happening in the more than 400 patients treated with CTL019/Kymriah manufactured by Novartis for clinical trials or the commercial setting.”

Louis Goss