Phase I study protocol: NKTR-255 as monotherapy or combined with daratumumab or rituximab in hematologic malignancies.
Nina ShahMiguel-Ángel PeralesCameron J TurtleMitchell S CairoAndrew J CowanHayder SaeedL Elizabeth Elizabeth BuddeAlan TanZachary LeeKazuharu KaiMario Q MarcondesJonathan ZalevskyMary A TagliaferriKrina K PatelPublished in: Future oncology (London, England) (2021)
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.
Keyphrases
- multiple myeloma
- open label
- phase ii
- diffuse large b cell lymphoma
- hodgkin lymphoma
- clinical trial
- study protocol
- recombinant human
- natural killer cells
- randomized controlled trial
- endothelial cells
- phase iii
- stem cells
- combination therapy
- acute lymphoblastic leukemia
- squamous cell carcinoma
- mesenchymal stem cells
- papillary thyroid
- double blind
- induced pluripotent stem cells
- bone marrow
- placebo controlled
- lymph node metastasis
- squamous cell
- pluripotent stem cells