Reengineered T-Cell Study Suspended After Patient Deaths

Memorial Sloan-Kettering Cancer Center has suspended patient recruitment for a study to reengineer T-cells due to safety concerns, according to FierceBiotech.

The closely watched but small study is using autologous T-cells re-engineered with chimeric antigen receptors against CD19-positive B-cells in patients with aggressive non-Hodgkin's lymphoma.

This evening, representatives for MSK told a meeting of the American Association for Cancer Research in San Diego that the trial was suspended following the deaths of two patients. Investigators believe they need to rethink the trial protocol on recruitment and change the patient profile to account for the threat of comorbidities while adjusting the dose "based on the extent of disease at the time of treatment."

At the meeting, MSK reps noted in their presentation that of 22 patients recruited, 10 had already died – six from either disease relapse or progression, two from complications related to allogeneic bone marrow transplantation. An additional two patients died within two weeks of receiving a CAR-T cell infusion at the center of the study. Of those two patients, one had a history of cardiac disease, and one had persistent seizure activity.

Company states plans to restart trial soon

Juno Therapeutics is the biotech company formed to commercialize the effort to re-engineer T-cells, and tonight, it sent a statement to FierceBiotech that reads:

"Juno Therapeutics' partner institution Memorial Sloan Kettering Cancer Research Center proactively amended their protocols in the CD19 trial, which led to a hold while those amendments are reviewed. They are working closely with the FDA and all indications are that the trial will be enrolling again shortly. The MSKCC trial has shown the best response rate ever reported for salvage therapy in poor risk adult ALL. The Hutch and Seattle Children's Research Institute trials are unaffected and continue to show great promise. Juno's plans and timelines at MSKCC, The Hutch, Seattle Children's and other partner institutions are not impacted in any way and Juno plans to announce a further expansion of its plans in the coming weeks."

Source: FierceBiotech