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Clinical Trials

Date: 2016-04-20

Type of information: Presentation of results at a congress

phase: 1

Announcement: presentation of results at the American Association for Cancer Research (AACR) Annual Meeting

Company: Juno Therapeutics (USA - WA) Fred Hutchinson Cancer Research Center (USA - WA)

Product: JCAR016

Action mechanism:

cell therapy/immunotherapy product/gene therapy/CAR-T cell therapy.  JCAR016 is a WT-1 TCR cell therapy, a CD22-specific CAR T cell therapy.  CD22 is a cell surface protein  expressed by most B cell malignancies, including NHL, ALL, and CLL. Juno Therapeutics has licensed this technology from Opus Bio. This product candidate was originally developed at the NCI. It has a fully human scFv and a 4-1BB costimulatory domain. 

Disease: WT-1-expressing non-small cell lung cancer (NSCLC), mesothelioma

Therapeutic area: Cancer - Oncology

Country: USA

Trial details:

This phase I/II trial studies the side effects and best dose of genetically modified T cells in treating patients with stage III-IV non-small cell lung cancer (NSCLC) or mesothelioma. Many types of cancer cells, including NSCLC and mesothelioma, but not most normal cells, have a protein called Wilms tumor (WT)1 on their surfaces. This study takes a type of immune cell from patients, called T cells, and modifies their genes in the laboratory so that they are programmed to find cells with WT1 and kill them. The T cells are then given back to the patient. Cyclophosphamide and aldesleukin may also stimulate the immune system to attack cancer cells. Giving cyclophosphamide and aldesleukin with laboratory-treated T cells may help the body build an immune response to kill tumor cells. (NCT02408016)

Latest news:

* On April 20, 2016, Juno Therapeutics announced, in partnership with its collaborators, early clinical data from two oral presentations for JCAR016 at the American Association for Cancer Research (AACR) Annual Meeting 2016 in New Orleans, Louisiana. In an oral presentation, Phil Greenberg, M.D., Head of Program in Immunology at the Fred Hutchinson Cancer Research Center and Professor, Medicine/Oncology and Immunology, University of Washington, presented “Targeting Cancer with Engineered T Cells.” In this Phase I/II study designed to evaluate genetically modified T cells targeting WT-1 in WT-1-expressing non-small cell lung cancer and mesothelioma using a WT-1-specific T-cell receptor, WT-1 TCR. Five patients have been enrolled and three patients have been treated to date. Preliminary data show one mesothelioma patient with an ongoing partial response to the WT-1 TCR and one with stable disease. The responses appear to correlate with the pharmacokinetics of the engineered T cells, as the patient with the partial response had the best T cell expansion and persistence. The patient had progressed after multiple therapies, including chemotherapy and radiation, prior to receiving JTCR016. JTCR016 was generally well-tolerated in these three patients, with no evidence of severe CRS or severe neurotoxicity.

Is general: Yes