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12:00 AM
Apr 21, 2014
 |  BioCentury  |  Product Development

CAR hits pothole

Sloan Kettering's pause with CAR T cell therapy hasn't affected Juno partners

Patient deaths prompted Memorial Sloan Kettering Cancer Center to briefly halt enrollment and update inclusion criteria for its CD19 directed chimeric antigen receptor T cell therapy. But partner Juno Therapeutics Inc. and other CAR players don't think this will affect development of similar therapies.

Adoptive cell therapies are widely seen as the next great advance in the treatment of cancer.

"It's joined surgery, radiation therapy, and chemotherapy as a fourth effective way to treat some cancers," said Steven Rosenberg, chief of surgery at National Cancer Institute (NCI), in an interview broadcast on BioCentury This Week television on Jan. 26.

On April 6, researchers at Sloan Kettering (MSKCC) reported progress and a speed bump for autologous T cells expressing the 19-28z chimeric antigen receptor (CAR) specific to the CD19 antigen.

To create the therapy, T cells are harvested from a patient and transduced with a vector that expresses a synthetic receptor specific for CD19. The receptor consists of heavy and light antibody chains fused to one or more T cell costimulatory domains. When reintroduced to the patient, the T cells recognize and destroy cells expressing the CD19 antigen, which occurs on most B cell malignancies (see SciBX: Science-Business eXchange, Oct. 24, 2013).

Renier Brentjens presented updated data from MSKCC's Phase I trial in 22 adult patients with relapsed B cell acute lymphoblastic leukemia (ALL) who received 19-28z CAR T cell therapy after salvage chemotherapy. Brentjens, who is director of cellular therapeutics at MSKCC, presented the results at the American Association for Cancer Research meeting.

19-28z CAR T cell therapy led to overall complete responses in 18 (86%) patients.

But during the discussion, MSKCC revealed that on March 7 it paused enrollment across its trials of the therapy because of safety concerns. The center then worked with FDA to amend the trial protocols.

Late Friday Juno spokesperson Kim James told BioCentury in an email that MSKCC has resumed enrolling patients in all trials after FDA approved the amended protocols. James did not say how the protocols were amended; however, she told BioCentury in an earlier email that the proposed amendments would affect the inclusion criteria and doses, and that Juno's plans and timelines at MSKCC would not be affected.

According to James, 10 deaths occurred in the trial, two of them treatment-related.

James said, "The 2 patients whose deaths prompted the MSKCC to amend its...

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