Solid TumorsEarly Phase 1NCT07621471
IL-15 Enhanced NK Cell Therapy for Solid Tumors
A Early Phase 1 study testing IL-15 enhanced engineered NK cells in people with Solid Tumors and Metastatic Cancer, run by Genovn Therapeutics (Suzhou) Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Solid Tumors, Metastatic Cancer
- What is being tested?
- IL-15 enhanced engineered NK cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2026to 31 Dec 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- positive syphilis antibody;
- major surgery or vaccination within 28 days;
- prior cell therapy;
- severe allergy to study drugs;
- investigator judged unsuitable.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xinqiao Hospital
Chongqing
Xinqiao Hospital, +86-23-68763468, jiaqingzhu0801@outlook.com
About this study
Official title: A Single-Arm Clinical Study of IL-15 Enhanced Engineered NK Cells for Refractory Relapsed/Metastatic 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.
- Conditions
- Solid Tumors, Metastatic Cancer
- Being tested
- IL-15 enhanced engineered NK cells
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL-15 enhanced engineered NK cellsDrug
Genetically engineered NK cells expressing IL-15. Administered intravenously. See protocol for dose details.
IL-15 Enhanced Engineered NK CellsBiological
Genetically engineered NK cells expressing IL-15
| Study group | Role | What they receive |
|---|---|---|
| IL-15 Enhanced Engineered NK Cells | Experimental | Single arm. Patients receive IL-15 enhanced engineered NK cells after lymphodepletion chemotherapy. Receives: Drug: IL-15 enhanced engineered NK cells; Biological: IL-15 Enhanced Engineered NK Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicity (DLT)
Measured: Within 28 days after first infusion
Secondary outcomes (4)
Objective Response Rate (ORR)
Measured: Every 4 weeks for the first 6 months, then every 12 weeks through 24 months
Duration of Response (DOR)
Measured: 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
Progression-Free Survival (PFS)
Measured: 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
Overall Survival (OS)
Measured: From date of enrollment until date of death from any cause, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start8 Oct 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- IL-15 enhanced engineered NK cells in patients with refractory relapsed or metastatic solid tumors.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genovn Therapeutics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621471
- Sponsor's protocol ID
- 2026-08-02
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Clinical Study of IL-15 Enhanced Engineered NK Cells for Refractory Relapsed/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07621471
- Acronym / sponsor ID
- 2026-08-02
- Conditions
- Solid Tumors, Metastatic Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Genovn Therapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- IL-15 enhanced engineered NK cells in patients with refractory relapsed or metastatic solid tumors.
| Arm | Type | Receives |
|---|---|---|
| IL-15 Enhanced Engineered NK Cells | Experimental | Drug: IL-15 enhanced engineered NK cells, Biological: IL-15 Enhanced Engineered NK CellsSingle arm. Patients receive IL-15 enhanced engineered NK cells after lymphodepletion chemotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (11 listed)
- Pregnancy/lactation;
- other malignancy within 5 years (except cured localized tumors);
- active autoimmune disease or immunodeficiency;
- uncontrolled cardiovascular disease or infection;
- active TB;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IL-15 enhanced engineered NK cellsGenetically engineered NK cells expressing IL-15. Administered intravenously. See protocol for dose details. | Drug | IL-15 Enhanced Engineered NK Cells |
| IL-15 Enhanced Engineered NK CellsGenetically engineered NK cells expressing IL-15 | Biological | IL-15 Enhanced Engineered NK Cells |
Primary outcome
Incidence of Dose-Limiting Toxicity (DLT)
Time frame: Within 28 days after first infusion
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: Every 4 weeks for the first 6 months, then every 12 weeks through 24 months
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
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
Overall Survival (OS)
Time frame: From date of enrollment until date of death from any cause, assessed up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing IL-15 enhanced engineered NK cells in people with Solid Tumors and Metastatic Cancer, run by Genovn Therapeutics (Suzhou) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicity (DLT) (time frame: Within 28 days after first infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.