Receive our newsletter – data, insights and analysis delivered to you
  1. Market Data
November 24, 2016

Juno Therapeutics halts Phase III ROCKET trial of JCAR015 to treat leukaemia

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.

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 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.

Content from our partners
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success
Patient-centric pharma logistics: How CRYOPDP delivers hope worldwide
Why Asia-Pacific is the next frontier for decentralized clinical trials

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.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU