Three Deaths In Trial Mean Clinical Hold For Juno’s Lead CAR-T Therapy

 
• By Mandy Jackson
  
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Juno Therapeutics Inc. planned to win US FDA approval in 2017 for its chimeric antigen receptor T cell (CAR-T) cell therapy JCAR015, but the company has reached another significant milestone that may delay that goal: its Phase II ROCKET clinical trial in the treatment of adults with relapsed or refractory B cell acute lymphoblastic lymphoma (ALL) has been put on clinical hold due to three deaths.

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Juno Therapeutics Inc. planned to win US FDA approval in 2017 for its chimeric antigen receptor T cell (CAR-T) cell therapy JCAR015, but the company has reached another significant milestone that may delay that goal: its Phase II ROCKET clinical trial in the treatment of adults with relapsed or refractory B cell acute lymphoblastic lymphoma (ALL) has been put on clinical hold due to three deaths.

Juno recently instituted a new pre-conditioning regimen in ROCKET that added fludarabine to cyclophosphamide chemotherapy, which was administered before the...

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