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NKTR-255 in Relapsed / Refractory Multiple Myeloma & Non-Hodgkin Lymphoma

Trial Status: Active

Patients will receive intravenous (IV) NKTR-255 in 21-day treatment cycles. During the Part 1 dose escalation portion of the trial, NKTR-255 will be given as monotherapy. After determination of the recommended Phase 2 dose (RP2D) of NKTR-255, NKTR-255 will be evaluated in 3 expansion Cohorts in Part 2 with daratumumab subcutaneous (DARZALEX FASPRO TM) and rituximab. Cohort A will enroll Non-Hodgkin Lymphoma (NHL) patients that have relapsed after CAR-T therapy. Cohort B will enroll patients with relapsed / refractory Multiple Myeloma (MM). Cohort C will enroll patients with relapsed / refractory indolent Non-Hodgkin Lymphoma (iNHL). This is a Phase 1 study to evaluate safety and tolerability of NKTR-255 alone and in combination with daratumumab or rituximab.

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 the following laboratory test results during Screening:
  • Absolute neutrophil count (ANC) or absolute granulocyte count (AGC) ≥ 1000/µL
  • Platelets ≥ 30,000/µL
  • Hemoglobin ≥ 8g/dL
  • Absolute lymphocytes ≥ 500/µL
  • 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 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 3 months washout.

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 3 months washout.
  • Patients who have had < 28 days since the last anti-cancer treatment, chemotherapy, biological therapy, or < 14 days from approved anti-myeloma agents, 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)

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
San Francisco
UCSF Medical Center-Mount Zion
Status: ACTIVE
Contact: Helen Diller Family Comprehensive Cancer Center
Phone: 877-827-3222

Florida

Tampa
Moffitt Cancer Center
Status: ACTIVE

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE

Minnesota

Minneapolis
University of Minnesota / Masonic Cancer Center
Status: ACTIVE

North Carolina

Durham
Duke University Medical Center
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE

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 DARZALEX FASPRO TM or rituximab. 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.

Part 1 will enroll relapsed/refractory MM and NHL patients. In Part 2, Cohort A will enroll

NHL patients who have progressed on a chimeric antigen receptor T-cell (CAR-T) product,

Cohort B will enroll MM patients who previously received daratumumab and other anti-CD38

therapies to receive NKTR-255 alone and/or in combination with daratumumab, and Cohort C will

enroll iNHL patients who previously received rituximab and other therapies to receive

NKTR-255 alone and/or in combination with rituximab.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Nektar

  • Primary ID 18-255-02
  • Secondary IDs NCI-2019-07642
  • Clinicaltrials.gov ID NCT04136756