The FDA has ordered Cellectis to shut down two Phase 1 trials for prospective cancer therapy UCART123 after a patient in the studies died nine days after treatment.
Just last week, the FDA approved its first CAR-T therapy, giving Novartis the green light to market Kymriah to treat children and young adults with relapsed acute lymphoblastic leukemia.
Cellectis, a french biopharma company, said a 78-year old man suffering from lymphoma died after experiencing cytokine release syndrome (CRS), a common immune system reaction to CAR-T treatments.
“Cellectis is working closely with the investigators and the FDA in order to resume the trials with an amended protocol including a lowered dosing of UCART123,” said the company in a press release.
Read the press release