Status:
COMPLETED
NKTR-255 in Relapsed/Refractory Multiple Myeloma & Non-Hodgkin Lymphoma
Lead Sponsor:
Nektar Therapeutics
Conditions:
Multiple Myeloma
Non-Hodgkin Lymphoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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...
Detailed 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 escalat...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
October 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04136756
Start Date
October 7 2019
End Date
April 24 2023
Last Update
June 15 2023
Active Locations (13)
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1
Western Regional Medical Center - CTCA
Goodyear, Arizona, United States, 85338
2
City of Hope
Duarte, California, United States, 91010
3
University of California, San Francisco
San Francisco, California, United States, 94143
4
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612