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RecruitingNCT07621471Updated Sep 30, 2026

IL-15 Enhanced NK Cell Therapy for Solid Tumors

An Early Phase 1 interventional study of IL-15 enhanced engineered NK cells and IL-15 Enhanced Engineered NK Cells in Solid Tumors and Metastatic Cancer, sponsored by Genovn Therapeutics (Suzhou) Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Genovn Therapeutics (Suzhou) Co., Ltd. · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Solid Tumors
  • Metastatic Cancer

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03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 18-70 years;
  2. ECOG 0-1;
  3. histopathologically confirmed metastatic or recurrent solid tumors (breast, liver, lung, etc.);
  4. failed prior standard therapy;
  5. >=1 measurable lesion per RECIST 1.1;
  6. adequate bone marrow, liver, kidney, and coagulation function;
  7. recovered from prior treatment toxicities;
  8. signed informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy/lactation;
  2. other malignancy within 5 years (except cured localized tumors);
  3. active autoimmune disease or immunodeficiency;
  4. uncontrolled cardiovascular disease or infection;
  5. active TB;
  6. positive HBsAg/HBcAb or HCV antibody (unless viral load undetectable);
  7. positive syphilis antibody;
  8. major surgery or vaccination within 28 days;
  9. prior cell therapy;
  10. severe allergy to study drugs;
  11. investigator judged unsuitable.
04

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    IL-15 Enhanced Engineered NK Cells

    Single arm. Patients receive IL-15 enhanced engineered NK cells after lymphodepletion chemotherapy.

    Drug: IL-15 enhanced engineered NK cells · Biological: IL-15 Enhanced Engineered NK Cells

Interventions

  • DrugIL-15 enhanced engineered NK cells

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

  • BiologicalIL-15 Enhanced Engineered NK Cells

    Genetically engineered NK cells expressing IL-15

05

What researchers measure

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

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07621471
Lead sponsor
Genovn Therapeutics (Suzhou) Co., Ltd.
Responsible party
Sponsor
First posted
Jun 2, 2026
Start date
Oct 8, 2026 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Sep 30, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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