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REStoring lymphoCytes Using NKTR-255* After chemoradiothErapy in Solid Tumors (RESCUE)

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment39 people
  • Recruiting US sites1
  • SponsorM.D. Anderson Cancer Center
  • RegistryNCT05632809

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

REStoring lymphoCytes Using NKTR-255* After chemoradiothErapy in Solid Tumors (RESCUE): a one-minute explainerNCT056328091 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join if

  • Age 18 years or older
  • Histologic diagnosis of non-small cell lung cancer
  • Written consent obtained before initiation of any study-related procedures
  • Definitive cancer treatment intent
  • Absence of concurrent malignancies at other sites, except low risk prostate cancer and basal cell of the skin. Participants with prior cancers should not be receiving active cancer treatment within the past 3 months. Cancer survivors who have undergone potentially curative therapy for a prior malignancy who have no evidence of that disease for 1 year and who are deemed at low risk for recurrence are eligible for the study.
  • Adequate liver (AST, ALT, Alk Phos, and Tbili <2 fold upper limit) and kidney function (Cr < 2.5 limit of normal and Cr clearance >30)
  • ECOG 0-2

You cannot join if

  • Subjects are to be excluded from the study if any of the following conditions apply:
  • HIV infection, cellular immune deficiencies, hypogammaglobulinemia or dysgammaglobulinemia, or hereditary or congenital immunodeficiencies
  • Prior diagnosis of hepatitis B or C (unless anti-hepatitis C therapy has produced a sustained virologic response);
  • History of clinically significant autoimmune disease, Crohn's disease, ulcerative colitis, or inflammatory disease.
  • Serious concomitant disorder, including active systemic infection requiring treatment, as judged by the Investigator.
  • Known or suspected hypersensitivity to any component of the investigational product
  • Recurrent radiation to the treatment site
  • Prior major surgery within 4 weeks of enrollment from which the patient has not recovered
  • Other condition or prior therapy that, in the opinion of the Investigator, compromises the subject's welfare or may confound study results
  • Previous enrollment in this study
  • Pregnancy: a female subject defined as a WOCBP who has a positive urine pregnancy test (e.g. within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Prior exposure to any anti-PD-1 or anti-PD-L1 antibody.
  • Patients must be capable of understanding and providing a written informed consent.
  • Patients with leukemias or lymphomas with T cell/histiocyte or NK cell rich component(s) and other variants not otherwise specified that contain high numbers of T or NK cells.
  • Evidence of clinically significant interstitial lung disease or active noninfectious pneumonitis during the course of chemoradiation that is unresolved to ≤ grade 1.
  • Patients with grade 4 toxicities during chemoradiation not resolved to grade ≤ 1 by the end of chemoradiation.
  • Prior exposure to IL-2 or IL-5.

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

polymer-conjugated IL-15 receptor agonist NKTR-255. A long-acting formulation composed of the human cytokine interleukin-15 (IL-15) that is conjugated by polymers, with potential immunomodulating and anti-tumor activities. Upon administration of polymer-conjugated IL-15 receptor agonist NKTR-255, the IL-15 moiety targets and binds to the alpha subunit of the IL-15 receptor on natural killer (NK) and T cells, thereby activating the IL-15-mediated pathway. This leads to the expansion and activation of natural killer (NK) cells and memory CD8+ T cells, thereby enhancing the anti-tumor activity of NKs and long-term memory T-lymphocyte immune responses. This may increase tumor cell killing and decrease tumor cell proliferation. In addition, NKTR-255 may, when combined with a tumor-directed antibody, enhance the antibody-dependent cell-mediated cytotoxicity (ADCC) mechanism. IL-15 is a pro-inflammatory cytokine that plays a key role in the regulation of T- and NK cell activation, proliferation and promotion of their anti-tumor effects. Compared to IL-15 alone, the polymer formulation allows for increased retention at the tumor site and reduced clearance, thereby increasing the effect of IL-15. NCI Drug Dictionary

durvalumab. A monoclonal antibody directed against B7H1 (B7 homolog 1; programmed cell death ligand 1) with potential immunostimulating activity. Upon intravenous administration, durvalumab binds to the cell surface antigen B7H1, thereby blocking B7H1 signaling. This may activate the immune system to exert a cytotoxic T-lymphocyte (CTL) response against B7H1-expressing tumor cells. B7H1, a member of the B7 protein superfamily and a negative regulator of cytokine synthesis, is overexpressed on certain tumor cell types. NCI Drug Dictionary

Treatments listed in the registry

  • NKTR-255 (Drug): Given by IV (vein)
  • Durvalumab (Drug): Given by IV (vein)

The study

Treatment groups

Na · Single Group · masking: None

NKTR-255 combination (Durvalumab) (Experimental)

Participants will receive vein over about 30 minutes. Participants receive the first dose within 72 hours (3 days) after you complete CRT and the second dose at 3 weeks after you complete CRT. Then, you will receive NKTR-255 one (1) time every 4 weeks after that for up to 1 year. Durvalumab Participants will receive durvalumab by vein over about 30 minutes. You will receive the first dose at 3 weeks after you complete CRT therapy. Then, you will receive durvalumab one (1) time every 4 weeks after that for up to 1 year

Goals

What the study measures

Main goals

  • Overall survival time distribution (through study completion; an average of 1 year)

Planned enrollment: 39 (estimated).

Where

Recruiting US sites

  • M D Anderson Cancer Center, Houston, Texas

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Jul 28, 2026. Public record; not medical advice.

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