NKTR-255 in Relapsed/Refractory Multiple Myeloma & Non Hodgkin Lymphoma & Combined With Daratumumab for Multiple Myeloma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04136756 |
Recruitment Status :
Recruiting
First Posted : October 23, 2019
Last Update Posted : October 23, 2019
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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 |
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Multiple Myeloma Non Hodgkin Lymphoma | Drug: NKTR-255 Drug: Daratumumab | Phase 1 |
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.
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 |

Arm | Intervention/treatment |
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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.
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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.
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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 |
- 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.
- 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

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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 |
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:
- Absolute neutrophil count (ANC) or absolute granulocyte count (AGC) ≥ 1000/µL
- Platelets ≥ 30,000/µL
- Hemoglobin ≥ 8g/dL
- Absolute lymphocytes ≥ 800/µL
- 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)

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
Contact: Nektar Recruitment | 855-482-8676 | StudyInquiry@nektar.com | |
Contact: Rebecca Sutton | 855-482-8676 |
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 |
Study Director: | Mario Marcondes, MD, PhD | Nektar Therapeutics |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
relapsed refractory NKTR-255 CAR-T |
daratumumab interleukin-15 (IL-15) MM NHL |
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 |