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Clinical Trial 20361

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT04136756

Phase: Phase I
Prinicipal Investigator:

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Overview

Study Title

A Phase 1, Open-Label, Multi-Center, Dose Escalation and Dose Expansion Study of NKTR-255 As A Single Agent In Relapsed Or Refractory Hematological Malignancies and In Combination With Daratumumab As A Salvage Regimen for Multiple Myeloma

Summary

This is a Phase 1, open-label, multi-center, dose escalation, dose expansion, safety follow-up, and survival follow-up of NKTR-255 as a single agent and NKTR-255 in combination with daratumumab or ritixumab. NKTR-255 is a cytokine that is designed to regulate T and natural killer cell activation, proliferation and promote their anti-tumor effects.

Objective

Phase 2 dose (RP2D) of NKTR-255 as a single agent. Part 2 (Dose Expansion): To evaluate the safety and tolerability of NKTR-255 in patients with relapsed or refractory multiple myeloma (MM) or non-Hodgkin lymphoma (NHL); and To evaluate the safety and tolerability of NKTR-255

Treatments

Therapies

Medications

Daratumumab (); NKTR-255 ()

Inclusion Criteria

> Patients must have relapsed or refractory MM or NHL with no available therapies that would confer clinical benefit for their primary disease.

  • Measurable or detectable disease according to International Myeloma Working Group (IMWG) and the Lugano Classification. Extranodal NHL disease that is measurable by fluorodeoxyglucose-positron emission tomography (FDG-PET) imaging only is allowed.
  • Estimated glomerular filtration rate (eGFR) ≥ 40 mL/min/1.73 m2.
  • Patient has laboratory test results as defined in the protocol during screening.
  • Patients are eligible who also meet all the following criteria in these cohorts of Part 2: Cohort A only:
  • Patients with NHL who received a commercially approved CD19 CAR-T product and had PD. The first dose of NKTR-255 will be administered within 30 days of the PD. Cohort B only:
  • Patients with MM must have had previous exposure to proteasome inhibitor, immunomodulatory agent (IMiD), and anti-CD38 therapy.
  • Patients who previously received daratumumab or other anti-CD38 therapies must have at least 6 months washout. Cohort C only:
  • Patients with relapsed or refractory iNHL who previously progressed during or following 1 or more prior systemic rituximab-containing (or another treatment with an anti-CD20 antibody-containing) regimens for lymphoma.

  • Exclusion Criteria

    > Patients who have an active, known, or suspected autoimmune disease.

  • Any treatment-related neurotoxicity or cytokine release syndrome (CRS) prior to enrollment into the study should return to baseline before NKTR-255 treatment.
  • Active central nervous system (CNS) involvement with NHL.
  • Patients who have been previously treated with prior interleukin-2 or interleukin-15.
  • Patients who received daratumumab or other anti-CD38 therapies previously must have 6 months washout.
  • Patients who have had over 28 days since the last anti-cancer treatment, chemotherapy, biological therapy, or over 14 days from approved tyrosine kinase inhibitor therapy (sunitinib, sorafenib, vemurafenib, dabrafenib, cobimetinib), or systemic or inhaled steroid therapy at doses greater than 10 mg of prednisone or equivalent before administration of the first dose of study drug(s).
  • Prolonged Fridericia's corrected QT interval (QTcF) > 450 ms for men and > 470 ms for women at Screening.
  • Contraindication to or unable to receive daratumumab (Cohort B only)

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