NKTR-255 in Relapsed/Refractory Multiple Myeloma & Non-Hodgkin Lymphoma
Condition: Multiple Myeloma; Non-Hodgkin Lymphoma; Indolent Non-Hodgkin Lymphoma
MeSH terms: Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 1

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 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.
    

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 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 multiple myeloma (MM) and Non-Hodgkin's Lymphoma (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 indolent Non-Hodgkin's Lymphoma (iNHL)
      patients who previously received rituximab and other therapies to receive NKTR-255 alone
      and/or in combination with rituximab.
    

Intervention name(s): NKTR-255; NKTR-255 Q21; Rituximab; Daratumumab
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): NKTR-255 administered by IV infusion every 21 or 28 days to establish safety and tolerability; NKTR-255 administered by IV infusion every 21 days to establish safety and tolerability; Rituximab administered intravenously at specified dose on specified days; Daratumumab administered subcutaneously at specified dose on specified days
Other intervention name(s): RITUXAN(R); DARZALEX FASPRO(TM)
Intervention MeSH terms: Rituximab; Daratumumab
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: relapsed; refractory; NKTR-255; CAR-T; daratumumab subcutaneous (sc); interleukin-15 (IL-15); MM; NHL; indolent; rituximab; Truxima®