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Multiple MyelomaPhase 1NCT04136756

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

A Phase 1 study testing NKTR-255, NKTR-255 Q21 and Rituximab in people with Multiple Myeloma and Non-Hodgkin Lymphoma, run by Nektar Therapeutics at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
NKTR-255, NKTR-255 Q21 and Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
13 sitesUnited States
Study dates
7 Oct 2019to 24 Apr 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have relapsed or refractory MM or NHL with no available therapies that would confer clinical benefit for their primary disease.
  • For MM patients, measurable relapsed or refractory MM as defined by the IMWG Criteria (Kumar, 2016) following treatment with at least 3 lines of therapy with no other available treatment that would confer benefit.
  • For NHL patients, 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.
  • Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2
  • Patient has the following laboratory test results during Screening:
Show all 19Show fewer
  • 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:
  • NKTR-255 Monotherapy NHL Group 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.
  • NKTR-255 with Daratumumab MM Group 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.
  • NKTR-255 with Rituximab Group iNHL Group 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.

Who cannot join

  • 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.
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322

  • City of Hope

    Duarte, California, 91010

  • Duke University Health System

    Durham, North Carolina, 27705

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Western Regional Medical Center - CTCA

    Goodyear, Arizona, 85338

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of California, San Francisco

    San Francisco, California, 94143

  • University of Washington

    Seattle, Washington, 98109

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

  • New York Medical College

    Valhalla, New York, 10595

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Multi-center, Dose Escalation and Dose Expansion Study of NKTR-255 in Relapsed or Refractory Hematological Malignancies

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.

Read the 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.

Being tested
NKTR-255, NKTR-255 Q21, Rituximab, Daratumumab
Keywords
relapsed, refractory, NKTR-255, CAR-T, daratumumab subcutaneous (sc), interleukin-15 (IL-15), MM, NHL, indolent, rituximab, Truxima®
Medical subject headings
Multiple Myeloma, Lymphoma, Non-Hodgkin, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NKTR-255Drug

    NKTR-255 administered by IV infusion every 21 or 28 days to establish safety and tolerability

  • NKTR-255 Q21Drug

    NKTR-255 administered by IV infusion every 21 days to establish safety and tolerability

  • RituximabDrug

    Also called RITUXAN(R)

    Rituximab administered intravenously at specified dose on specified days

  • DaratumumabDrug

    Also called DARZALEX FASPRO(TM)

    Daratumumab administered subcutaneously at specified dose on specified days

Study groups in NCT04136756
Study groupRoleWhat they receive
Dose EscalationExperimentalEvaluation of NKTR-255 as: * Monotherapy * In combination with daratumumab * In combination with rituximab This phase will help to determine the RP2D of NKTR-255
Receives: Drug: NKTR-255; Drug: Rituximab; Drug: Daratumumab
Dose Expansion Cohort AExperimentalEvaluation of RP2D of NKTR-255 as monotherapy in patients with NHL relapsed after CAR-T
Receives: Drug: NKTR-255
Dose Expansion Cohort BExperimentalEvaluation of RP2D of NKTR-255 as monotherapy and in combination with SC daratumumab in patients with R/R MM
Receives: Drug: NKTR-255; Drug: Daratumumab
Dose Expansion Cohort CExperimentalEvaluation of RP2D of NKTR-255 as monotherapy and in combination with rituximab in patients with R/R iNHL
Receives: Drug: NKTR-255 Q21; Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events of NKTR-255 as a single agent

    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.

    Measured: Through study completion, an expected average of 6 months

  2. Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events of NKTR-255 with daratumumab SC

    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

    Measured: Through study completion, an expected average of 1 year

  3. Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events of NKTR-255 with rituximab

    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

    Measured: Through study completion, an expected average of 1 year

  4. Evaluate the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of NKTR-255 as a single agent

    Measured: Through study completion, an expected average of 6 months

  5. Evaluate the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of NKTR-255 in combination with daratumumab SC

    Measured: Through study completion, an expected average of 1 year

  6. Evaluate the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of NKTR-255 in combination with rituximab

    Measured: Through study completion, an expected average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2019
  2. Study start7 Oct 2019
  3. Primary completion24 Apr 2023
  4. Study completion24 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04136756
Sponsor's protocol ID
18-255-02
Status last verified
Jun 2023
First submitted
9 Oct 2019
Last updated
15 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shah N, Perales MA, Turtle CJ, Cairo MS, Cowan AJ, Saeed H, Budde LE, Tan A, Lee Z, Kai K, Marcondes MQ, Zalevsky J, Tagliaferri MA, Patel KK. Phase I study protocol: NKTR-255 as monotherapy or combined with daratumumab or rituximab in hematologic malignancies. Future Oncol. 2021 Sep;17(27):3549-3560. doi: 10.2217/fon-2021-0576. Epub 2021 Jun 22.

    PubMed 34154392

  • Miyazaki T, Maiti M, Hennessy M, Chang T, Kuo P, Addepalli M, Obalapur P, Sheibani S, Wilczek J, Pena R, Quach P, Cetz J, Moffett A, Tang Y, Kirk P, Huang J, Sheng D, Zhang P, Rubas W, Madakamutil L, Kivimae S, Zalevsky J. NKTR-255, a novel polymer-conjugated rhIL-15 with potent antitumor efficacy. J Immunother Cancer. 2021 May;9(5):e002024. doi: 10.1136/jitc-2020-002024.

    PubMed 34001523

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NKTR-255, NKTR-255 Q21 and Rituximab in people with Multiple Myeloma and Non-Hodgkin Lymphoma, run by Nektar Therapeutics at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04136756, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.

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