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

doi:10.2217/fon-2021-0576

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

Lymphoma-Myeloma

Research output: Contribution to journal › Article › peer-review

11 Scopus citations

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.

Original language	English (US)
Pages (from-to)	3549-3560
Number of pages	12
Journal	Future Oncology
Volume	17
Issue number	27
DOIs	https://doi.org/10.2217/fon-2021-0576
State	Published - Sep 2021

Keywords

IL-15
NKTR-255
daratumumab
multiple myeloma
non-Hodgkin lymphoma
rituximab
study protocol

ASJC Scopus subject areas

Oncology
Cancer Research

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Shah, N., Perales, M. A., Turtle, C. J., Cairo, M. S., Cowan, A. J., Saeed, H., Budde, L. E., Tan, A., Lee, Z., Kai, K., Marcondes, M. Q., Zalevsky, J., Tagliaferri, M. A., & Patel, K. K. (2021). Phase i study protocol: NKTR-255 as monotherapy or combined with daratumumab or rituximab in hematologic malignancies. Future Oncology, 17(27), 3549-3560. https://doi.org/10.2217/fon-2021-0576

Shah, N, Perales, MA, Turtle, CJ, Cairo, MS, Cowan, AJ, Saeed, H, Budde, LE, Tan, A, Lee, Z, Kai, K, Marcondes, MQ, Zalevsky, J, Tagliaferri, MA & Patel, KK 2021, 'Phase i study protocol: NKTR-255 as monotherapy or combined with daratumumab or rituximab in hematologic malignancies', Future Oncology, vol. 17, no. 27, pp. 3549-3560. https://doi.org/10.2217/fon-2021-0576

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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.",

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author = "Nina Shah and Perales, {Miguel Angel} and Turtle, {Cameron J.} and Cairo, {Mitchell S.} and Cowan, {Andrew J.} and Hayder Saeed and Budde, {Lihua E.} and Alan Tan and Zachary Lee and Kazuharu Kai and Marcondes, {Mario Q.} and Jonathan Zalevsky and Tagliaferri, {Mary A.} and Patel, {Krina K.}",

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AU - Budde, Lihua E.

AU - Tan, Alan

AU - Lee, Zachary

AU - Kai, Kazuharu

AU - Marcondes, Mario Q.

AU - Zalevsky, Jonathan

AU - Tagliaferri, Mary A.

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AB - 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.

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KW - NKTR-255

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Phase i study protocol: NKTR-255 as monotherapy or combined with daratumumab or rituximab in hematologic malignancies

Abstract

Keywords

ASJC Scopus subject areas

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