NKTR-255 in Relapsed/Refractory Multiple Myeloma & Non-Hodgkin Lymphoma
Multiple Myeloma, Non-Hodgkin Lymphoma, Indolent Non-Hodgkin Lymphoma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring relapsed, refractory, NKTR-255, CAR-T, daratumumab subcutaneous (sc), interleukin-15 (IL-15), MM, NHL, indolent, rituximab, Truxima®
Eligibility Criteria
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.
- 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.
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.
- 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
Sites / Locations
- Western Regional Medical Center - CTCA
- City of Hope
- University of California, San Francisco
- H. Lee Moffitt Cancer Center and Research Institute
- Winship Cancer Institute, Emory University
- University of Michigan
- University of Minnesota
- Memorial Sloan Kettering Cancer Center
- New York Medical College
- Duke University Health System
- MD Anderson Cancer Center
- Virginia Cancer Specialists
- University of Washington
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Dose Escalation
Dose Expansion Cohort A
Dose Expansion Cohort B
Dose Expansion Cohort C
Evaluation of NKTR-255 as: Monotherapy In combination with daratumumab In combination with rituximab This phase will help to determine the RP2D of NKTR-255
Evaluation of RP2D of NKTR-255 as monotherapy in patients with NHL relapsed after CAR-T
Evaluation of RP2D of NKTR-255 as monotherapy and in combination with SC daratumumab in patients with R/R MM
Evaluation of RP2D of NKTR-255 as monotherapy and in combination with rituximab in patients with R/R iNHL