Blood Collection. Each patient will have two - 10 mL vials of blood collected at the following timepoints: baseline, 9 ± 1 weeks on trial treatment, at time of confirmed response (if applicable) and at the EOT. Blood samples will be processed for serum and for peripheral blood mononuclear cells (PBMCs). Viable PBMCs will be stored in Bambanker™ freezing media for later analysis of circulating immune cells by existing technologies, such as flow cytometry, CyTOF, single-cell RNA-Seq, and single cell ATAC-Seq, as well as various new technologies as they become available. Serum will be snap frozen and used to evaluate the impact of therapies on circulating cytokine levels (e.g. IL6) by ELISA and multiplex cytokine assays. Specific details for blood sample collection and handling will be provided to the investigative sites in the Trial Laboratory Manual.
Blood Collection. Patients will be in a seated or supine position during the blood collection. Specific instructions for sample collection, processing, and shipping will be provided in a separate laboratory manual. If central laboratory tests results are not obtainable in a timely manner, samples may be collected at an unscheduled visit and analyzed locally. See the laboratory manual for additional information.
