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

  • STATUS
    Recruiting
  • End date
    Jan 5, 2023
  • participants needed
    118
  • sponsor
    Nektar Therapeutics
Updated on 5 April 2022
lymphoma
multiple myeloma
hodgkin's disease
rituximab
white blood cells
neutrophil count
daratumumab
proteasome inhibitor
primary disease
refractory multiple myeloma
immunotherapeutic agent
immunomodulatory imide drug

Summary

Patients will receive intravenous (IV) NKTR-255 in 21 or 28 day treatment cycles. During the Part 1 dose escalation portion of the trial, patients will either receive NKTR-255 as monotherapy, NKTR-255 administered as a doublet with daratumumab subcutaneous (DARZALEX FASPRO TM), or NKTR-255 administered as a doublet with rituximab. After determination of the recommended Phase 2 dose (RP2D) of NKTR-255, NKTR-255 will be evaluated in Part 2. During the Part 2 dose expansion portion of the trial, patients will either receive NKTR-255 as monotherapy, NKTR-255 administered as a doublet with daratumumab subcutaneous (DARZALEX FASPRO TM), or NKTR-255 administered as a doublet with rituximab.

This is a Phase 1 study to evaluate safety and tolerability of NKTR-255 alone and in combination with daratumumab or rituximab.

Description

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 multiple myeloma (MM) and Non-Hodgkin's Lymphoma (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 indolent Non-Hodgkin's Lymphoma (iNHL) patients who previously received rituximab and other therapies to receive NKTR-255 alone and/or in combination with rituximab.

Details
Condition Multiple Myeloma, Non-Hodgkin Lymphoma, Indolent Non-Hodgkin Lymphoma
Treatment Rituximab, Daratumumab, NKTR-255, NKTR-255 Q21
Clinical Study IdentifierNCT04136756
SponsorNektar Therapeutics
Last Modified on5 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients must have relapsed or refractory MM or NHL with no available therapies that would confer clinical benefit for their primary disease
For MM patients, measurable relapsed or refractory MM as defined by the IMWG Criteria (Kumar, 2016) following treatment with at least 3 lines of therapy with no other available treatment that would confer benefit
For NHL patients, 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
Patient has the following laboratory test results during Screening
Estimated glomerular filtration rate (eGFR) ≥ 40 mL/min/1.73 m2
Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2
Absolute neutrophil count (ANC) or absolute granulocyte count (AGC) ≥ 1000/µL
Platelets ≥ 30,000/µL
Hemoglobin ≥ 8g/dL
Absolute lymphocytes ≥ 500/µL
Patients are eligible who also meet all the following criteria in these
Leukocytes ≥ 3000/µL
cohorts of Part 2
NKTR-255 Monotherapy NHL Group 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
NKTR-255 with Daratumumab MM Group 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
NKTR-255 with Rituximab Group iNHL Group 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 3 months washout
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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