Tag Archives: clinical trial materials

FDA Removes Clinical Hold on Phase II of Juno’s “ROCKET” Trial

On Tuesday, July 12, 2016, Juno Therapeutics, a biopharmaceutical company developing cell-based cancer immunotherapies headquartered in Seattle, Washington, announced on the company’s website that the U.S. Food and Drug Administration (FDA) removed the clinical hold on the Phase II clinical trial of JCAR015 (known as the “ROCKET” trial) in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL).  Under the revised protocol, the ROCKET trial will continue enrollment using JCAR015 with cyclophosphamide pre-conditioning only.

CAR-T

Earlier this month Juno received notice from the (FDA) that a clinical trial hold has been placed on the pivotal clinical trial of JCAR015.  This Phase II clinical trial, also known as the “ROCKET” trial, was being conducted in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL).  As of last Friday, a total of three deaths have occurred in adult patients during clinical trials.

According to an article published by FierceBiotech on July 8, 2016, “All three deaths were in young patients, all under the age of 25, and all were due to cerebral edema.  All three of these patients were also on a preconditioning regimen of fludarabine.”

While this “living drug” may offer cancer patients a possible option where none previously existed, it is uncertain as to whether or not the class of chimeric antigen receptor T cells (CAR-T) treatments poses safety issues.  This new technology focuses on re-engaging a patient’s own immune system (T cells) via genetically engineering to recognize the antigen and kill cancerous cells.  One big question is:  Can this be done in conjunction with standard leukemia chemotherapy drugs like fludarabine and cyclophosphamide?

The removal of the clinical hold suggests that the FDA appears to satisfied with Juno’s response in addressing worrisome side effect and safety concerns resulting from the reaction between JCAR015 and the chemotherapy drug fludarabine.

Phase I of the JCAR015 study had a “complete response rate” (i.e., detectable cancer did not appear present after treatment), this cancer treatment offers much promise and hope to individuals and families battling this devastating and too often fatal disease.

For more information about how Sentry can implement a custom solution to provide GMP storage for clinical trial materials and/or meet your unique biopharmaceutical supply chain challenges, contact Sentry via email or by phone at 1-866-757-7400, for a complimentary, no obligation phone call with one of Sentry’s problem-solving experts.

Sentry – Vetter Joint Clinical Trial Delivery System

Safeguarding the health of clinical trial participants and the progression of trial results demands strict adherence to protocols. A disciplined approach to project management adds value within the constraints of client needs, including time and budget.

Sentry BioPharma Services (Sentry) provides clinical trial services to clients utilizing contract manufacturing organizations (CMO). Throughout Sentry’s history we have developed strong ties to contract manufacturers and their pharmaceutical and biotechnology clients by providing the following services:

  •  Cold chain management activities
  •  Drug product shipping services for worldwide international and domestic distribution
  •  Drug product returns and destruction programs
  •  GMP compliant drug product storage (ambient to <-135°C)
  •  Import/export optimization including foreign trade zone (FTZ) status
  •  Labeling, kitting and secondary packaging

As a continuation of Sentry’s CMO extended services, Sentry BioPharma Services and Vetter Development Service USA (Vetter) have announced their combined services offering to support new drug development from compound through clinic trials. From planning to filling to tracking, Vetter and Sentry will guide your compound through the clinical trial manufacturing process.