Phase I study protocol: NKTR-255 as monotherapy or combined with daratumumab or rituximab in hematologic malignancies Journal Article
| Authors: | 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. |
| Article Title: | Phase I study protocol: NKTR-255 as monotherapy or combined with daratumumab or rituximab in hematologic malignancies |
| 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. © 2021 Future Medicine Ltd.. All rights reserved. |
| Keywords: | unclassified drug; major clinical study; drug tolerability; cancer recurrence; drug safety; recommended drug dose; rituximab; methodology; cd8 antigen; cd8+ t lymphocyte; cell proliferation; cancer immunotherapy; multiple cycle treatment; multiple myeloma; cohort analysis; antineoplastic activity; drug dose escalation; cd20 antigen; nonhodgkin lymphoma; immune response; genetic engineering; multicenter study; natural killer cell; maximum tolerated dose; phase 1 clinical trial; interleukin 15; macrogol; cd19 antigen; non-hodgkin lymphoma; il-15; cytokine receptor antagonist; interleukin 15 receptor; human; article; daratumumab; chimeric antigen receptor t-cell immunotherapy; clinical trial protocol; study protocol; nktr-255; nktr 255; first in human study |
| Journal Title: | Future Oncology |
| Volume: | 17 |
| Issue: | 27 |
| ISSN: | 1479-6694 |
| Publisher: | Future Medicine |
| Date Published: | 2021-09-01 |
| Start Page: | 3549 |
| End Page: | 3560 |
| Language: | English |
| DOI: | 10.2217/fon-2021-0576 |
| PUBMED: | 34154392 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Article -- Export Date: 1 October 2021 -- Source: Scopus |
