NKTR-255 in Relapsed/Refractory Multiple Myeloma & Non-Hodgkin Lymphoma
Multiple Myeloma
Non-Hodgkin Lymphoma
18 - 80 Years, Male and Female
18-255-02 (primary)
NCI-2019-07642
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.
Objectives
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.
Eligibility
- 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.
- Estimated glomerular filtration rate (eGFR) = 40 mL/min/1.73 m2.
- Eastern Cooperative Oncology Group (ECOG) performance status score = 2 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: 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.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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