Second Cellectis CAR-T Therapy On Clinical Hold, Dosing Could Be Issue

 
• By Mandy Jackson

A Phase I study for allogeneic therapy UCARTCS1A was put on clinical hold after a patient died. High dosing and double exposure to cyclophosphamide pre-conditioning may have played a role. 

long exposure on road at night
A Phase I trial for UCARTCS1A was halted after a patient died from cardiac arrest • Source: Shutterstock

The US Food and Drug Administration put the Phase I MELANI-01 clinical trial for Cellectis SA’s allogeneic chimeric antigen receptor T-cell (CAR-T) therapy UCARTCS1A on clinical hold after a multiple myeloma patient treated with the CS1-targeting treatment died from cardiac arrest. This is the second time that one of the company’s wholly owned CAR-T candidates has been subject to a clinical hold after the death of a patient.

Cellectis announced the setback after the US stock market closed on 6 July, and the company’s share price fell 14.3%...

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