Clinical trial · Interventional
NKTR-255 in Relapsed/Refractory Multiple Myeloma & Non-Hodgkin Lymphoma
A Phase 1, Open-label, Multi-center, Dose Escalation and Dose Expansion Study of NKTR-255 in Relapsed or Refractory Hematological Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Indolent Non-Hodgkin Lymphoma | Indolent Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Daratumumab | Drug | Daratumumab | ALIAS |
| NKTR-255 | Drug | — | UNRESOLVED |
| NKTR-255 Q21 | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- 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
- interventionNames
- Drug: NKTR-255
- Drug: Rituximab
- Drug: Daratumumab
- type
- EXPERIMENTAL
- label
- Dose Expansion Cohort A
- description
- Evaluation of RP2D of NKTR-255 as monotherapy in patients with NHL relapsed after CAR-T
- interventionNames
- Drug: NKTR-255
- type
- EXPERIMENTAL
- label
- Dose Expansion Cohort B
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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. * 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: 1. Absolute neutrophil count (ANC) or absolute granulocyte count (AGC) ≥ 1000/µL 2. Platelets ≥ 30,000/µL 3. Hemoglobin ≥ 8g/dL 4. Absolute lymphocytes ≥ 500/µL 5. 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. 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. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
References
Publications (2)
- DERIVEDShah 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. PMID 34154392
- DERIVEDMiyazaki 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. PMID 34001523