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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
NKTR-255 administered by IV infusion every 21 or 28 days to establish safety and tolerability
NKTR-255 administered by IV infusion every 21 days to establish safety and tolerability
Rituximab administered intravenously at specified dose on specified days
Daratumumab administered subcutaneously at specified dose on specified days
Western Regional Medical Center - CTCA
Goodyear, Arizona, United States
City of Hope
Duarte, California, United States
University of California, San Francisco
San Francisco, California, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
New York Medical College
Valhalla, New York, United States
Duke University Health System
Durham, North Carolina, United States
...and 3 more locations
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events of NKTR-255 as a single agent
Safety and tolerability of NKTR-255 as evaluated by incidence of Dose Limiting Toxicities (DLTs), drug-related Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to discontinuation, deaths, clinical laboratory abnormalities per CTCAE v5.
Time frame: Through study completion, an expected average of 6 months
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events of NKTR-255 with daratumumab SC
Safety and tolerability of NKTR-255 in combination with daratumumab as evaluated by incidence of drug-related AEs, SAEs, AEs leading to discontinuation, deaths, clinical laboratory abnormalities per CTCAE v5
Time frame: Through study completion, an expected average of 1 year
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events of NKTR-255 with rituximab
Safety and tolerability of NKTR-255 in combination with rituximab as evaluated by incidence of drug-related AEs, SAEs, AEs leading to discontinuation, deaths, clinical laboratory abnormalities per CTCAE v5
Time frame: Through study completion, an expected average of 1 year
Evaluate the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of NKTR-255 as a single agent
Time frame: Through study completion, an expected average of 6 months
Evaluate the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of NKTR-255 in combination with daratumumab SC
Time frame: Through study completion, an expected average of 1 year
Evaluate the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of NKTR-255 in combination with rituximab
Time frame: Through study completion, an expected average of 1 year
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