NKTR-255 in Relapsed/Refractory Multiple Myeloma & Non-Hodgkin Lymphoma
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ClinicalTrials.gov Identifier: NCT04136756 |
Recruitment Status :
Recruiting
First Posted : October 23, 2019
Last Update Posted : March 12, 2021
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Patients will receive intravenous (IV) 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, NKTR-255 will be evaluated in 3 expansion Cohorts in Part 2 with daratumumab subcutaneous (DARZALEX FASPRO TM) and rituximab. Cohort A will enroll Non-Hodgkin Lymphoma (NHL) patients that have relapsed after CAR-T therapy. Cohort B will enroll patients with relapsed/refractory Multiple Myeloma (MM). Cohort C will enroll patients with relapsed/refractory indolent Non-Hodgkin Lymphoma (iNHL).
This is a Phase 1 study to evaluate safety and tolerability of NKTR-255 alone and in combination with daratumumab or rituximab.
Condition or disease | Intervention/treatment | Phase |
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Multiple Myeloma Non-Hodgkin Lymphoma Indolent Non-Hodgkin Lymphoma | Drug: NKTR-255 Drug: Daratumumab Drug: Rituximab | 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 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 MM and 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 iNHL patients who previously received rituximab and other therapies to receive NKTR-255 alone and/or in combination with rituximab.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 118 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 |
Actual Study Start Date : | October 7, 2019 |
Estimated Primary Completion Date : | April 2022 |
Estimated Study Completion Date : | September 2022 |

Arm | Intervention/treatment |
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Experimental: Dose Escalation of NKTR-255
Patients will receive IV infusion of NKTR-255 every 21 or 28 days to establish RP2D.
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Drug: NKTR-255
NKTR-255 administered by IV infusion every 21 or 28 days to establish safety and tolerability |
Experimental: Dose Expansion of NKTR-255 alone
The selected RP2D of NKTR-255 will be evaluated in expansion cohorts. Cohort A in patients with relapsed NHL after CAR-T therapy as a salvage regimen to further characterize safety and tolerability. Cohort B1 will evaluate NKTR-255 in patients with MM with progressive disease who have had at least 3 prior lines of therapy treatment. Cohort C1 will evaluate patients with 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.
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Drug: NKTR-255
NKTR-255 administered by IV infusion every 21 or 28 days to establish safety and tolerability |
Experimental: Dose Expansion of NKTR-255 with Daratumumab
The selected RP2D of NKTR-255 will be evaluated in expansion Cohort B2, which will combine NKTR-255 with daratumumab in patients with MM with progressive disease who have had at least 3 prior lines of therapy treatment.
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Drug: NKTR-255
NKTR-255 administered by IV infusion every 21 or 28 days to establish safety and tolerability Drug: Daratumumab Daratumumab administered subcutaneously at specified dose on specified days
Other Name: DARZALEX FASPRO(TM) |
Experimental: Dose Expansion of NKTR-255 with Rituximab
The selected RP2D of NKTR-255 will be evaluated in Cohort C2, which will combine NKTR-255 with rituximab in patients with 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.
|
Drug: NKTR-255
NKTR-255 administered by IV infusion every 21 or 28 days to establish safety and tolerability Drug: Rituximab Rituximab administered intravenously at specified dose on specified days
Other Name: RITUXAN(R) |
- 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
- Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events of NKTR-255 with Rituximab [ Time Frame: Through study completion, an expected average of 1 year ]Safety and tolerability of NKTR-255 in combination with rituximab as evaluated by incidence of drug-related AEs, SAEs, AEs leading to discontinuation, deaths, clinical laboratory abnormalities per CTCAE v5

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 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.
- 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 ≥ 500/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 who 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.
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 3 months washout.
Cohort C only:
• Patients with relapsed or refractory iNHL who previously progressed during or following 1 or more prior systemic rituximab-containing (or another treatment with an anti-CD20 antibody-containing) regimens for lymphoma.
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.
- 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 must have 3 months washout.
- Patients who have had < 28 days since the last anti-cancer treatment, chemotherapy, biological therapy, or < 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)
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

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: Medical Affairs | 855-482-8676 | medicalaffairs@nektar.com |
United States, Arizona | |
CTCA Phoenix | Recruiting |
Goodyear, Arizona, United States, 85338 | |
United States, California | |
City of Hope | Recruiting |
Duarte, California, United States, 91010 | |
University of California at San Francisco | Recruiting |
San Francisco, California, United States, 94143 | |
United States, Florida | |
H Lee Moffitt Cancer Center and Research Institute | Recruiting |
Tampa, Florida, United States, 33612 | |
United States, Georgia | |
Winship Cancer Institute, Emory University | Recruiting |
Atlanta, Georgia, United States, 30322 | |
United States, Illinois | |
Rush University Medical Center | Active, not recruiting |
Chicago, Illinois, United States, 60612 | |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
United States, Minnesota | |
University of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
United States, New York | |
Memorial Sloan Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
New York Medical College | Recruiting |
Valhalla, New York, United States, 10595 | |
United States, North Carolina | |
Duke University Health System | Recruiting |
Durham, North Carolina, United States, 27705 | |
United States, Texas | |
MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
United States, Virginia | |
Virginia Cancer Specialists | Recruiting |
Fairfax, Virginia, United States, 22031 | |
United States, Washington | |
University of Washington | Recruiting |
Seattle, Washington, United States, 98109 |
Study Director: | Study Director | Nektar Therapeutics |
Responsible Party: | Nektar Therapeutics |
ClinicalTrials.gov Identifier: | NCT04136756 |
Other Study ID Numbers: |
18-255-02 |
First Posted: | October 23, 2019 Key Record Dates |
Last Update Posted: | March 12, 2021 |
Last Verified: | March 2021 |
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 subcutaneous (sc) |
interleukin-15 (IL-15) MM NHL indolent rituximab |
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 Rituximab Daratumumab Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |