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NCT Number: NCT07621471

IL-15 Enhanced NK Cell Therapy for Solid Tumors

A single-arm, Phase 1 study evaluating safety, tolerability, and preliminary efficacy of IL-15 enhanced engineered NK cells in patients with refractory relapsed or metastatic solid tumors.

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Key information

Conditions

Solid Tumors Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-70 years;
  • ECOG 0-1;
  • histopathologically confirmed metastatic or recurrent solid tumors (breast, liver, lung, etc.);
  • failed prior standard therapy;
  • >=1 measurable lesion per RECIST 1.1;
  • adequate bone marrow, liver, kidney, and coagulation function;
  • recovered from prior treatment toxicities;
  • signed informed consent.

Exclusion criteria

  • Pregnancy/lactation;
  • other malignancy within 5 years (except cured localized tumors);
  • active autoimmune disease or immunodeficiency;
  • uncontrolled cardiovascular disease or infection;
  • active TB;
  • positive HBsAg/HBcAb or HCV antibody (unless viral load undetectable);
  • positive syphilis antibody;
  • major surgery or vaccination within 28 days;
  • prior cell therapy;
  • severe allergy to study drugs;
  • investigator judged unsuitable.

Treatment and study plan

IL-15 enhanced engineered NK cells

Drug

Genetically engineered NK cells expressing IL-15. Administered intravenously. See protocol for dose details.

IL-15 Enhanced Engineered NK Cells

Biological

Genetically engineered NK cells expressing IL-15

Primary outcomes

  1. Incidence of Dose-Limiting Toxicity (DLT)

    Time frame: Within 28 days after first infusion

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Every 4 weeks for the first 6 months, then every 12 weeks through 24 months

  2. Duration of Response (DOR)

    Time frame: From date of first documented response until date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

  3. Progression-Free Survival (PFS)

    Time frame: From date of enrollment until date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

  4. Overall Survival (OS)

    Time frame: From date of enrollment until date of death from any cause, assessed up to 24 months

Other outcomes

  1. Expansion and persistence of IL-15 enhanced engineered NK cells and cytokine levels

    Time frame: Baseline (Day 0), Day 1, Day 3, Day 7, Day 14, Day 28, then every 4 weeks through 6 months, then every 12 weeks through 12 months

Sponsors and collaborators

Lead sponsor

Genovn Therapeutics (Suzhou) Co., Ltd.

Industry

Registry information

Official study title

A Single-Arm Clinical Study of IL-15 Enhanced Engineered NK Cells for Refractory Relapsed/Metastatic Solid Tumors

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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