The Worldwide Master Protocol, called the QUILT Program, will be designed under the CRADA (Cooperative Research and Development Agreement) agreements between pharmaceutical/biotechnology companies and U.S.A.'s NCI (National Cancer Institute), with the scientific guidance of the Branch Chiefs of Tumor Immunology and Biology Laboratory and Medical Oncology at the NCI, and in accordance with the recently published FDA guidance of “Co-development of Two or More New Investigational Drugs for Use in Combination.” The FDA’s involvement relates to providing guidance on our protocols. The NCI’s involvement is at the branch level of vaccine and tumor immunology and oncology divisions. Their involvement would be in the scientific input to the clinical trial design as part of their responsibilities inside the CRADA.

The QUILT Program (QUantum Immuno-oncology Lifelong Trial) is designed to harness and orchestrate all the elements of the immune system (including dendritic cell, T cell, and NK cell therapies) by testing novel combinations of vaccines, cell-based immunotherapy, metronomic chemotherapy, low dose radiotherapy and immunomodulators, including check point inhibitors, in patients who have undergone next generation whole genome, transcriptome and quantitative proteomic analysis, with the goal of achieving durable, long-lasting remission for patients with cancer.

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