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NKTR-255 in relapsed/refractory multiple myeloma & non-Hodgkin lymphoma & combined with daratumumab for multiple myeloma

Description

This study is a phase 1, open-label, multi-center dose escalation and dose expansion study in patients with relapsed or refractory multiple myeloma or non-Hodgkin lymphoma.

Status

Accepting new patients

Primary Study Objective(s)

The primary objectives of this trial are:

Part 1 (Dose Escalation):

  • To evaluate the safety, tolerability, maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of NKTR-255 as a single agent

Part 2 (Dose Expansion):

  • To evaluate the safety and tolerability of NKTR-255 in patients with relapsed multiple myeloma (MM) or non-Hodgkin lymphoma
  • To evaluate the safety and tolerability of NKTR-255 in combination with daratumumab in patients with relapsed or refractory MM

 

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Have relapsed or refractory multiple myeloma or non-Hodgkin lymphoma with no available therapies that would confer clinical benefit for their primary disease and must meet the specific disease criteria described
  • Are 18 to 75 years of age, inclusive at study entry
  • Have Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2
  • Have estimated glomerular filtration rate (eGFR) ≥ 40 mL/min/1.73 m2
  • Have not been previously treated with interleukin-2 or interleukin-15
  • Received CD19 CAR-T for non-Hodgkin lymphoma, or BCMA CAR-T or anti-CD38 therapies for multiple myeloma after confirmation of relapse of the primary disease
  • Have the following laboratory test results during screening:
    • Absolute neutrophil count (ANC) or absolute granulocyte count (AGC) ≥ 1000/μL
    • Platelets ≥ 30,000/μL
    • Hemoglobin ≥ 8 g/dL
    • Absolute lymphocytes ≥ 800/μL
    • Leukocytes ≥ 3000/μL

Note: Any treatment-related neurotoxicity or CRS prior to enrollment into the study should return to baseline before NKTR-255 treatment

Key eligibility criteria for multiple myeloma

  • Have measurable relapsed or refractory myeloma as defined by the IMWG Consensus Criteria (Kumar, 2016) following treatment with at least three lines of therapy with no other available treatment that would confer benefit
  • Have progression on, or within 60 days of completion of the last therapy and measurable disease within at least one of the following:
    • Serum M-protein level ≥ 0.5 g/dL or
    • Urine M-protein level ≥ 200 mg/24 hours
    • Serum free light chain (FLC) assay: involved FLC level ≥ 0.5 g/dL and an abnormal serum FLC ratio (< 0.26 or > 1.65)
    • Biopsy proven plasmacytoma (measured within 28 days of screening)

Key eligibility criteria for non-Hodgkin lymphoma

  • Have histologically confirmed as CD19/CD20 positive non-Hodgkin lymphoma (including large B-cell lymphoma, high grade B-cell lymphoma, PMBCL, or DLBCL, arising from follicular lymphoma) confirmed by archived tumor biopsy tissue from last relapse and corresponding pathology report
  • Have measurable or detectable disease according to the Lugano classification (Cheson, 2014)
  • Have extranodal disease that is measurable by fluorodeoxyglucose-positron emission tomography (FDG-PET) imaging only will also be allowed
  • Have no active central nervous system (CNS) involvement with non-Hodgkin lymphoma

Additional key eligibility criteria for part 2 dose expansion

  • Cohort A non-Hodgkin lymphoma and multiple myeloma only:
    • Patients with non-Hodgkin lymphoma may have 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
    • Patients with multiple myeloma may have received a BCMA CAR-T product and had PD. The first dose of NKTR-255 will be administered within 30 days of the PD
  • Cohort B multiple myeloma only:
    • Refractory disease is defined as PD while on therapy or progression within 60 days of therapy
    • PD is defined by IMWG criteria (Appendix 2)
    • 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 six months washout
     

Accepting new patients

 

Learn more at

clinicaltrials.gov

 

Principal Investigator(s)

Alan Tan