Gene-Edited T Cell Therapy Players Battle Safety Doubts

Confidence in gene-edited T cell therapies from donor cells has faltered as Allogene Therapeutics paused all clinical development following the detection of an unexpected genetic change in a clinical trial. Industry experts see these events as a reality check for the nascent field.

Off-the-shelf treatments that use genetically engineered T cells to treat diseases suffered a blow to their image earlier this month when a gene-edited Chimeric Antigen Receptor (CAR)-T cell therapy, developed by the US biotech Allogene Therapeutics, encountered a safety concern in a phase I/II trial.

According to Allogene, a biopsy from a blood cancer patient infused with its CAR-T cell therapy revealed CAR-T cells with an unexplained chromosomal change. The company noted that the abnormality was found on a chromosome that’s also targeted by TALEN-based gene-editing technology used by the firm. It’s still unclear if the change originated from the gene-editing process, and what its clinical impact could be.

The FDA has put a hold on all clinical trials involving Allogene’s CAR-T cell therapy,

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