For the second time in 5 months, Juno Therapeutics has put a clinical hold on a Phase II trial of JCAR015 in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia due to patient deaths. Two patients suffered cerebral edema earlier this week; one patient has died and the other is not expected to recover. Five deaths are now associated with this trial.
It seems unlikely that this hold will be lifted as quickly as the July hold was following a protocol change, if at all.
The company is evaluating its options regarding the JCAR015 program. At this time, trials and plans for its other CD19-directed chimeric antigen receptor (CAR) T-cell product candidates, including JCAR017, are not affected.
Juno's share price has fallen over 30% and is now trading at $20.62.