US-based biopharmaceutical company Juno Therapeutics has halted its Phase III ROCKET trial of JCAR015 to treat adult patients with relapsed or refractory B-cell acute lymphoblastic leukaemia.
JCAR015 is based on Juno’s CAR and T-cell receptor (TCR) technologies and is an investigational CD19-targeted chimeric antigen receptor (CAR) modified T-cell product.
The Rocket trial was being conducted as a single-arm, multicentre study to analyse the safety and efficacy of JCAR015 in Adult Subjects with relapsed or refractory B-cell acute lymphoblastic leukaemia.
The clinical hold was implemented after one patient died due to cerebral edema and another patient was in a terminal condition.
The US Food and Drug Administration (FDA) has been notified of the voluntary hold by the company, which is now working with the agency and the Data and Safety Monitoring Board to determine the next steps.
The company is examining data from the cases and the trial and is exploring its options related to the JCAR015 programme.
However, the hold will not affect Juno’s planned trials of other CD19-directed CAR T-cell product candidates, including JCAR017.
In June, the FDA had halted the Rocket trail following the death of two patients after the addition of fludarabine to the preconditioning regimen, reported Ascopost.
The hold was removed after Juno submitted a revised protocol of the trial, under which the company continued enrolling patients using JCAR015 with cyclophosphamide preconditioning only.