NKTR-255 in Relapsed/Refractory Multiple Myeloma & Non Hodgkin Lymphoma & Combined With Daratumumab for Multiple Myeloma

Overview

NKTR-255 is a cytokine that is designed to regulate T and natural killer cell activation, proliferation and promote their anti-tumor effects.

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. Study treatment is defined as any investigational treatment(s) or marketed product(s), intended to be administered to a study patient according to the study enrollment.

The NKTR-255 starting dose in Dose Group 1 will be 1.5 µg/kg. Patients will receive intravenous (IV) NKTR-255 in 21-day cycles, starting on Cycle 1 Day 1.

SparkCures ID 1045
Trial Phase Phase 1
Enrollment 82 Patients
Treatments
Trial Sponsors
  • Nektar Therapeutics
NCT Identifier

NCT04136756

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Key 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.
  • No active central nervous system (CNS) involvement with NHL.
  • Estimated glomerular filtration rate (eGFR) ≥ 40 mL/min/1.73 m2

Patient has the following laboratory test results during Screening:

  1. Absolute neutrophil count (ANC) or absolute granulocyte count (AGC) ≥ 1000/µL
  2. Platelets ≥ 30,000/µL
  3. Hemoglobin ≥ 8g/dL
  4. Absolute lymphocytes ≥ 800/µL
  5. Leukocytes ≥ 3000/µL

Patients are eligible who also meet all the following criteria in these cohorts of Part 2:

Cohort A only:

  • Patients with NHL may have 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.
  • Patients with MM may have received a B cell maturation antigen (BCMA) 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

Key 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.

  • 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 < 28 days since the last anti-cancer treatment, chemotherapy, biological therapy, or < 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)

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Cancer Treatment Centers of America Western Regional Medical Center

Goodyear, AZ

Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

Verified Winship Cancer Institute of Emory University

SparkCures Verified Accurate, up-to-date information. Learn more


New York Medical College

Valhalla, NY

University of Washington School of Medicine

Seattle, WA

Arizona
Cancer Treatment Centers of America Western Regional Medical Center

Goodyear, AZ

California
Florida
Georgia
Verified Winship Cancer Institute of Emory University

SparkCures Verified Accurate, up-to-date information. Learn more

Michigan
New York
New York Medical College

Valhalla, NY

North Carolina
Texas
Virginia
Washington
University of Washington School of Medicine

Seattle, WA

Resources

There are no resources, links or videos to display for this clinical trial.