Phase I study protocol: NKTR-255 as monotherapy or combined with daratumumab or rituximab in hematologic malignancies
Nina Shah, Miguel-Angel Perales, Cameron J Turtle, Mitchell S Cairo, Andrew J Cowan, Hayder Saeed, Lihua E Budde, Alan Tan, Zachary Lee, Kazuharu Kai, Mario Q Marcondes, Jonathan Zalevsky, Mary A Tagliaferri, Krina K Patel, Nina Shah, Miguel-Angel Perales, Cameron J Turtle, Mitchell S Cairo, Andrew J Cowan, Hayder Saeed, Lihua E Budde, Alan Tan, Zachary Lee, Kazuharu Kai, Mario Q Marcondes, Jonathan Zalevsky, Mary A Tagliaferri, Krina K Patel
Abstract
NKTR-255 is an investigational polyethylene glycol-modified recombinant human IL-15 (rhIL-15) receptor agonist, designed to improve the immunotherapeutic and anti-cancer benefit observed with rhIL-15 while circumventing the toxicities associated with this therapy. In preclinical studies, NKTR-255 has demonstrated enhanced proliferation and function of CD8+ T cells and natural killer cells, as well as enhanced anti-tumor activity and survival both as monotherapy and in combination with monoclonal antibodies in multiple cancer models. Here, we describe the rationale and design of the first-in-human Phase I, dose-escalation and dose-expansion study of NKTR-255 alone and in combination with daratumumab or rituximab in adults with relapsed/refractory multiple myeloma or non-Hodgkin's lymphoma that will determine the maximum tolerated dose and recommended Phase II dose for NKTR-255.
Trial registration: ClinicalTrials.gov NCT04136756.
Keywords: IL-15; NKTR-255; daratumumab; multiple myeloma; non-Hodgkin lymphoma; rituximab; study protocol.
Source: PubMed