Multiple Myeloma Clinical Trial
Official title:
A Phase 1, Open-label, Multi-center, Dose Escalation and Dose Expansion Study of NKTR-255 in Relapsed or Refractory Hematological Malignancies
Verified date | June 2023 |
Source | Nektar Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 24, 2023 |
Est. primary completion date | April 24, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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: 1. Absolute neutrophil count (ANC) or absolute granulocyte count (AGC) = 1000/µL 2. Platelets = 30,000/µL 3. Hemoglobin = 8g/dL 4. Absolute lymphocytes = 500/µL 5. 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
United States | Winship Cancer Institute, Emory University | Atlanta | Georgia |
United States | City of Hope | Duarte | California |
United States | Duke University Health System | Durham | North Carolina |
United States | Virginia Cancer Specialists | Fairfax | Virginia |
United States | Western Regional Medical Center - CTCA | Goodyear | Arizona |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | University of California, San Francisco | San Francisco | California |
United States | University of Washington | Seattle | Washington |
United States | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida |
United States | New York Medical College | Valhalla | New York |
Lead Sponsor | Collaborator |
---|---|
Nektar Therapeutics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Through study completion, an expected average of 6 months | |
Primary | 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 | Through study completion, an expected average of 1 year | |
Primary | 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 | Through study completion, an expected average of 1 year | |
Primary | Evaluate the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of NKTR-255 as a single agent | Through study completion, an expected average of 6 months | ||
Primary | Evaluate the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of NKTR-255 in combination with daratumumab SC | Through study completion, an expected average of 1 year | ||
Primary | Evaluate the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of NKTR-255 in combination with rituximab | Through study completion, an expected average of 1 year |
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