Clinical trial Recruiting at 1 site Early Phase 1 Interventional Ages 18 to 70

IL-15–Enhanced NK Cell Therapy for Solid Tumors

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

Run by Genovn Therapeutics PTE. LTD. · NCT07621471 · Data updated 2026-11-12

A first-in-human, early-phase study tests whether IL-15–enhanced engineered NK cells are safe and can show early signs of effect in adults with relapsed or metastatic solid tumors.

Quick facts

PhaseEarly Phase 1
Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment12 (estimated)
SponsorGenovn Therapeutics PTE. LTD.
Industry-sponsored
Locations1 site (Chongqing)
StatusRecruiting
StartedOctober 8, 2026
Main results expectedDecember 31, 2028
Study endsDecember 31, 2028
Registry record updatedSeptember 30, 2026
Trial IDNCT07621471 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18-70 with histologically confirmed metastatic or recurrent solid tumors who progressed after prior therapy and have at least one measurable lesion.

Probably not a fit

Patients with uncontrolled infections, autoimmune disease, major cardiovascular issues, or those who have received prior cell therapy may not benefit and could be at higher risk of adverse events.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm Phase 1 trial evaluating the safety and tolerability of IL-15 enhanced engineered natural killer (NK) cells in patients with refractory solid tumors. Participants receive the cell therapy after meeting eligibility criteria, including measurable disease and adequate organ function. The study will monitor adverse events and preliminary anti-tumor activity to inform future development. It is sponsored by Genovn Therapeutics (Suzhou) Co., Ltd. and conducted at Xinqiao Hospital in Chongqing.

Why it matters

Potential benefit: If successful, the therapy could offer a new cellular treatment option for patients with metastatic solid tumors who have exhausted standard therapies.

How similar studies have gone: Similar NK cell–based approaches have shown safety in early studies, with limited but encouraging signals of activity in some solid tumors.

Who can join: the full rules

Show full inclusion / exclusion criteria
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:

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.

Where it's running

  • Xinqiao Hospital
    Chongqing, China
    Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • BA1203 in advanced solid tumors: safety and early signs of activity

    This early-phase trial tests BA1203 in adults with advanced solid tumors to see if it is safe, tolerable, how the drug behaves in the body, and whether it shows any early signs of effectiveness.

    Recruiting Phase 1 Shandong Boan Biotechnology Co., Ltd · Beijing · NCT07876609

  • BL-M08D treatment in melanoma and other solid tumors

    A phase Ib/II study tests BL-M08D1 injections in adults with locally advanced or metastatic melanoma and other solid tumors to see if it is safe and helpful.

    Recruiting Phase 1/2 Sichuan Baili Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality · NCT07841925

  • REC-7735 for PIK3CA-H1047R-mutant solid tumors

    This study tests REC-7735 in people with unresectable, locally advanced, or metastatic solid tumors that carry the PIK3CA-H1047R mutation.

    Recruiting at 3 sites Phase 1/2 Recursion Pharmaceuticals Inc. · Grand Rapids, Michigan and 2 other locations · NCT07819136

  • Preferences of physicians and patients for cell therapies in advanced solid tumors

    This study tests how doctors and patients weigh the benefits, risks, and burdens of CAR-T, TIL, TCR-T, and NK cell therapies in advanced solid cancers.

    Recruiting Zhejiang University · Hangzhou, Zhejiang · NCT07813000

  • HP007 monotherapy for relapsed or advanced solid tumors

    This study tests HP007 as a standalone treatment in adults with hard-to-treat solid tumors to see if it is safe and tolerable and to look for early signs of activity.

    Recruiting Phase 1 Parr Biotechnology (Hebei) Co., Ltd. · Changchun, Jilin · NCT07800936

  • ONO-7429 in advanced or recurrent solid tumors

    This small early-phase study tests whether ONO-7429 is tolerable and safe in adults with unresectable advanced or recurrent solid tumors who have tried other treatments.

    Recruiting at 10 sites Phase 1 Ono Pharmaceutical Co., Ltd. · Kashiwa, Chiba and 9 other locations · NCT07787208

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.