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Trial record 1 of 1 for:    NKTR-255
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NKTR-255 in Relapsed/Refractory Multiple Myeloma & Non Hodgkin Lymphoma & Combined With Daratumumab for Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT04136756
Recruitment Status : Recruiting
First Posted : October 23, 2019
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Nektar Therapeutics

Brief Summary:

Patients will receive intravenous NKTR-255 in 21-day treatment cycles. During the Part 1 dose escalation portion of the trial, NKTR-255 will be given as monotherapy. After determination of the recommended Phase 2 dose (RP2D) of NKTR-255, approximately 18 Multiple Myeloma (MM) or non-Hodgkin lymphoma (NHL) patients who may have received a chimeric antigen receptor T-cell (CAR-T) product and had progressive disease (PD) will receive NKTR-255 and approximately 18 MM patients who previously received daratumumab or other anti-CD38 therapies will receive NKTR-255 and daratumumab.

Phase 1 study to evaluate safety and tolerability of NKTR-255 along and in combination with daratumumab in subjects with relapsed/refractory NHL and multiple myeloma.


Condition or disease Intervention/treatment Phase
Multiple Myeloma Non Hodgkin Lymphoma Drug: NKTR-255 Drug: Daratumumab Phase 1

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 daratumumab. 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.

The NKTR-255 starting dose in Dose Group 1 will be 1.5 µg/kg. Patients will receive intravenous (IV) NKTR-255 in 21-day cycles, starting on Cycle 1 Day 1.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 7, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Daratumumab

Arm Intervention/treatment
Experimental: Dose Escalation of NKTR-255
The NKTR-255 starting dose will be 1.5 µg/kg. Patients will receive intravenous (IV) NKTR-255 every 21 days (q21d) to establish RP2D.
Drug: NKTR-255
NKTR-255 administered by intravenous infusion (IV) every 21 days to establish safety and tolerability

Experimental: Dose Expansion of NKTR-255 alone and with Daratumumab
The selected RP2D of NKTR-255 will be evaluated in 2 expansion Cohorts (A and B). Cohort A will expand NKTR-255 in patients with relapsed MM or NHL as a salvage regimen to further characterize safety and tolerability. Cohort B will combine NKTR-255 with daratumumab in patients with MM with progressive disease who have had at least 3 prior lines of therapy treatment may continue if there is clinical benefit as determined by the Investigator.
Drug: NKTR-255
NKTR-255 administered by intravenous infusion (IV) every 21 days to establish safety and tolerability

Drug: Daratumumab
Daratumumab administered by IV at a dose of 16 mg/kg weekly for 8 weeks, then every 2 weeks for 16 weeks, and then every 4 weeks thereafter
Other Name: Darzalex




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events of NKTR-255 [ Time Frame: Through study completion, an expected average of 6 months ]
    Safety and tolerability of NKTR-255 as evaluated by incidence of Dose Limiting Toxicities (DLTs), drug-related Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to discontinuation, deaths, clinical laboratory abnormalities per CTCAE v5.

  2. Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events of NKTR-255 with Daratumumab [ Time Frame: Through study completion, an expected average of 1 year ]
    Safety and tolerability of NKTR-255 in combination with daratumumab as evaluated by incidence of drug-related AEs, SAEs, AEs leading to discontinuation, deaths, clinical laboratory abnormalities per CTCAE v5



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 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.
  • No active central nervous system (CNS) involvement with NHL.
  • Estimated glomerular filtration rate (eGFR) ≥ 40 mL/min/1.73 m2

Patient has the following laboratory test results during Screening:

  1. Absolute neutrophil count (ANC) or absolute granulocyte count (AGC) ≥ 1000/µL
  2. Platelets ≥ 30,000/µL
  3. Hemoglobin ≥ 8g/dL
  4. Absolute lymphocytes ≥ 800/µL
  5. 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 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 MM may have received a B cell maturation antigen (BCMA) 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 6 months washout

Key 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.

  • 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 6 months washout
  • Patients who have had < 28 days since the last anti-cancer treatment, chemotherapy, biological therapy, or < 14 days from approved tyrosine kinase inhibitor therapy (sunitinib, sorafenib, vemurafenib, dabrafenib, cobimetinib), 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04136756


Contacts
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Contact: Nektar Recruitment 855-482-8676 StudyInquiry@nektar.com
Contact: Rebecca Sutton 855-482-8676

Locations
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United States, Arizona
California Treatment Centers of America Recruiting
Goodyear, Arizona, United States, 85338
United States, California
University of California at San Francisco Not yet recruiting
San Francisco, California, United States, 94143
United States, Florida
H Lee Moffitt Cancer Center and Research Institute Not yet recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Winship Cancer Institute, Emory University Not yet recruiting
Atlanta, Georgia, United States, 30322
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48109
United States, New York
Memorial Sloan Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10065
New York Medical College Not yet recruiting
Valhalla, New York, United States, 10595
United States, North Carolina
Duke University Health System Not yet recruiting
Durham, North Carolina, United States, 27705
United States, Texas
MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
United States, Virginia
Virginia Cancer Specialists Not yet recruiting
Fairfax, Virginia, United States, 22031
United States, Washington
University of Washington Not yet recruiting
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Nektar Therapeutics
Investigators
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Study Director: Mario Marcondes, MD, PhD Nektar Therapeutics

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Responsible Party: Nektar Therapeutics
ClinicalTrials.gov Identifier: NCT04136756     History of Changes
Other Study ID Numbers: 18-255-02
First Posted: October 23, 2019    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nektar Therapeutics:
relapsed
refractory
NKTR-255
CAR-T
daratumumab
interleukin-15 (IL-15)
MM
NHL
Additional relevant MeSH terms:
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Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Daratumumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs