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Clinical Trial 20361

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT04136756

Phase: Phase I
Principal Investigator: Saeed, Hayder

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Study Title

A Phase 1, Open-Label, Multi-Center, Dose Escalation and Dose Expansion Study of NKTR-255 As A Single Agent In Relapsed Or Refractory Hematological Malignancies and In Combination With Daratumumab As A Salvage Regimen for Multiple Myeloma


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 daratumumab or ritixumab. NKTR-255 is a cytokine that is designed to regulate T and natural killer cell activation, proliferation and promote their anti-tumor effects.


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 or refractory multiple myeloma (MM) or non-Hodgkin lymphoma (NHL); and To evaluate the safety and tolerability of NKTR-255





Daratumumab (Darzalex); NKTR-255 (); Rituxan (rituximab); rituximab ()

Inclusion Criteria

> Patients with multiple myeloma (MM) must have measurable relapsed or refractory MM as defined by the IMWG Consensus Criteria following treatment with at least 3 lines of therapy with no other available treatment that would confer benefit.

  • 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; or Serum free light chain (FLC) assay: involved FLC level ≥ 10 mg/dL (100 mg/L) and an abnormal serum FLC ratio ( 1.65); or Extramedullary plasmacytoma (measured within 28 days of Screening) can be used to adjudicate response assessments by clinical investigators concurrently with either of above 3 markers. Non--Hodgkin Lymphoma
  • Histologically confirmed CD19/CD20 positive NHL (including large B--cell lymphoma, high grade B--cell lymphoma, primary mediastinal large B-cell lymphoma (PMBCL), or DLBCL, arising from follicular lymphoma) confirmed by archived tumor biopsy tissue from last relapse fresh biopsy at the time of inclusion Indolent Non--Hodgkin Lymphoma (iNHL)
  • Histologically confirmed CD19/CD20 positive diagnosis of iNHL (follicular lymphoma Grade 1, 2, 3a; marginal zone lymphoma; small lymphocytic lymphoma or lymphoplasmacytic lymphoma) confirmed by archived tumor biopsy tissue from last relapse or fresh biopsy at the time of inclusion.
  • Must have received treatment with at least 1 or more prior rituximab--containing regimens.
  • Anti--CD20 monoclonal antibody (mAb)-)-refractory disease OR anti-CD20 mAb-sensitive disease, as defined per protocol.
  • Patients with cutaneous only disease may be enrolled if they have a clearly measurable skin lesion. Inclusion Criteria for Dose Expansion: Patients are eligible who also meet all the following criteria in these cohorts of Part 2: Cohort A NHL only
  • Patients with NHL must have received a commercially approved CD19 CAR--T product and had PD. The first dose of NKTR--255 should be administered within 30 days of the PD. Cohort B MM only:
  • Relapsed or refractory disease defined as PD while on therapy or progression within 60 days of therapy.
  • Progressive disease as defined by IMWG criteria (Appendix 2)
  • Previous exposure to proteasome inhibitor, IMiD, and anti--CD38 therapy
  • Patients who previously received daratumumab or other anti--CD38 therapies must have at least 3 months washout
  • Responded at least once to prior daratumumab treatment Cohort C iNHL only:
  • Relapsed or refractory iNHL that has progressed during or following 1 or more prior systemic rituximab--containing (or another treatment with an anti-CD20 antibody containing) regimens for lymphoma.
  • Other criteria may apply

  • 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.
  • History of allergy of hypersensitivity to study drug components
  • History of organ transplant that requires ongoing use of immune supressive agents
  • 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 with less than 3 months washout
  • Use of warfarin within 14 days of initiating study drug(s)
  • Unresolved toxicity from previous anticancer therapy, unless resolved to Grade 1 or less, or Resolved to Grade 2 with exceptions outlined in study
  • Prior surgery or radiotherapy within 14 days of initiating study drug(s). Patients must have recovered from all radiation related toxicities, not required corticosteroids and have not had radiation pneumonitis.
  • Patients participating in observational studies should be discussed with the Medical Monitor to confirm eligibility.
  • Patients who have had over 28 days since the last anticancer treatment, chemotherapy, biological therapy, or over 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)
  • Other exclusions apply

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