NKTR-255 in Relapsed / Refractory Multiple Myeloma & Non-Hodgkin Lymphoma
- Patients must have relapsed or refractory MM or NHL with no available therapies that would confer clinical benefit for their primary disease.
- 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. 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: Cohort A 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. Cohort B 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.
- 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.
- Patients who have had < 28 days since the last anti-cancer treatment, chemotherapy, biological therapy, or < 14 days from approved anti-myeloma agents, or systemic or inhaled steroid therapy at doses greater than 10 mg of prednisone or equivalent before administration of the first dose of study drug(s).
- Prolonged Fridericia's corrected QT interval (QTcF) > 450 ms for men and > 470 ms for women at Screening.
- Contraindication to or unable to receive daratumumab (Cohort B only)
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 MM and 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 iNHL patients who previously received rituximab and other therapies to receive
NKTR-255 alone and/or in combination with rituximab.
Trial Phase Phase I
Trial Type Treatment
- Primary ID 18-255-02
- Secondary IDs NCI-2019-07642
- Clinicaltrials.gov ID NCT04136756