Date: 2014-12-08
Type of information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 6-9 in San Francisco, CA
Company: Juno Therapeutics (USA - WA)
Product: JCAR015 - autologous CD3+ T cells transduced with retroviral vector containing a chimeric antigen receptor directed against CD19 (Autologous CD3+ T cells containing CD19 chimeric antigen receptor)
Action
mechanism: cell therapy/immunotherapy product/gene therapy/CAR-T cell therapy. JCAR015 is based on chimeric antigen receptor (CAR) technology. T cells are removed from blood, transduced with retroviral vector containing a chimeric antigen receptor directed against CD19, and then put back in the body. This gene will produce proteins in the T cells that help the T cells recognize the leukemia cells and possibly kill them.
Disease: acute lymphoblastic leukemia
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: "Precursor B Cell Acute Lymphoblastic Leukemia (B-ALL) Treated With Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19" is an investigational approach that uses immune cells, called "T cells", to kill leukemia. The main goals of this study is to determine the safety and appropriate dose of these modified T cells in patients with ALL. This will be done in a "clinical trial." The dose of modified T-cells will depend on if you have disease present in your bone marrow or not. The patient will also receive chemotherapy before the T cells. We will use normally chemotherapy that is used in patients with leukemia. The chemotherapy is given to reduce leukemia and to allow the T cells to live longer. (NCT01044069)
Latest
news: * On December 8, 2014, Juno Therapeutics announced that clinical data from one ofits most advanced chimeric antigen receptor (CAR) product candidate, JCAR015, demonstrated encouraging evidence of clinical responses in acute lymphoblastic leukemia (ALL). Clinical results were presented in oral and poster presentations at the 56th American Society of Hematology (ASH) Annual Meeting in San Francisco, California. In an oral presentation on the Phase I clinical trial results of JCAR015 in adults with ALL, Jae H. Park, M.D. of the Leukemia Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, in New York City, presented: Complete remission occurred in 24/27 (89%) evaluable patients and complete molecular remission occurred in 21/24 (88%) evaluable patients with relapsed/refractory adult ALL. In this ongoing trial, median overall survival was 8.5 months. Durable responses were observed in patients with and without subsequent allogeneic stem cell transplant. Cytokine release syndrome (CRS) requiring vasopressors and/or mechanical ventilation was required for 5/15 patients with morphologic disease, or greater than 5% blasts in the bone marrow, and 0/13 patients without morphologic disease. Grade 3/4 neurotoxicity occurred in 7/28 patients and was generally reversible. In a poster presentation on the Phase I clinical trials results of JCAR017 in pediatric patients with ALL, Rebecca A. Gardner, M.D., of Ben Towne Center for Childhood Cancer Research, Seattle Children’s Research Institute, in Seattle, presented: Eleven of 13 (85%) patients with relapsed/refractory ALL following allogeneic stem cell transplantation obtained or maintained an MRD negative complete remission following CAR T cell therapy. All 11 responding patients exhibited in vivo expansion of CAR T cells (median peak CAR+ T cells of 478/uL [range 63-1288] occurring 7?14 days post infusion), with 6/8 (75.0%) of evaluable patients having CAR T cell persistence of more than 40 days. Two patients received treatment with steroids and tocilizumab for severe cytokine release syndrome. One of these patients experienced grade 4 encephalopathy and there was an additional patient that experienced grade 3 encephalopathy.
