NKTR-255 in Relapsed/Refractory Multiple Myeloma & Non-Hodgkin Lymphoma

Part of paid clinical trials in Goodyear, Arizona.

Sponsor
Nektar Therapeutics
Study ID
NCT04136756
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • NKTR-255 — DRUG
    NKTR-255 administered by IV infusion every 21 or 28 days to establish safety and tolerability
  • NKTR-255 Q21 — DRUG
    NKTR-255 administered by IV infusion every 21 days to establish safety and tolerability
  • Rituximab — DRUG
    Rituximab administered intravenously at specified dose on specified days
  • Daratumumab — DRUG
    Daratumumab administered subcutaneously at specified dose on specified days

Study Details

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.

Key Dates

Start date
Oct 7, 2019
Status verified
Jun 2023
Primary completion
Apr 24, 2023
Completion
Apr 24, 2023

Study Design

Enrollment
30 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    Evaluation of NKTR-255 as: * Monotherapy * In combination with daratumumab * In combination with rituximab This phase will help to determine the RP2D of NKTR-255
  • Experimental: Dose Expansion Cohort A
    Evaluation of RP2D of NKTR-255 as monotherapy in patients with NHL relapsed after CAR-T
  • Experimental: Dose Expansion Cohort B
    Evaluation of RP2D of NKTR-255 as monotherapy and in combination with SC daratumumab in patients with R/R MM
  • Experimental: Dose Expansion Cohort C
    Evaluation of RP2D of NKTR-255 as monotherapy and in combination with rituximab in patients with R/R iNHL

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events of NKTR-255 as a single agent [ Time Frame: Through study completion, an expected average of 6 months ]

Locations (13)

FacilityCityStateZIPSite coordinators
Western Regional Medical Center - CTCAGoodyearArizona85338-
City of HopeDuarteCalifornia91010-
University of California, San FranciscoSan FranciscoCalifornia94143-
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
Winship Cancer Institute, Emory UniversityAtlantaGeorgia30322-
University of MichiganAnn ArborMichigan48109-
University of MinnesotaMinneapolisMinnesota55455-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
New York Medical CollegeValhallaNew York10595-
Duke University Health SystemDurhamNorth Carolina27705-
MD Anderson Cancer CenterHoustonTexas77030-
Virginia Cancer SpecialistsFairfaxVirginia22031-
University of WashingtonSeattleWashington98109-

Find similar trials in Goodyear, AZ

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Western Regional Medical Center - CTCA· Goodyear, AZCity of Hope· Duarte, CAUniversity of California, San Francisco· San Francisco, CAH. Lee Moffitt Cancer Center and Research Institute· Tampa, FLWinship Cancer Institute, Emory University· Atlanta, GAUniversity of Michigan· Ann Arbor, MI

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