Solid Tumor, Malignant AscitesPhase 1/2NCT06991478
SK-NK Injection in Patients With Advanced Solid Tumors Accompanied by Malignant Ascites
A Phase 1/2 study testing SK-NK injection in people with Solid Tumor, Malignant Ascites, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
This study is divided into two phases. Patients with recurrent or metastatic solid tumors accompanied by malignant ascites who have failed previous standard treatments are enrolled. The first phase is a single-arm, open-dose exploratory Phase I clinical study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor, Malignant Ascites
- What is being tested?
- SK-NK injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2025to 30 Jul 2026
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years.
- Malignant solid tumors confirmed by histology or pathology, including: advanced gastric cancer, colorectal cancer, esophageal squamous cell carcinoma, gynecological malignancies, etc. that have failed at least two lines of treatment.
- Pathological diagnosis or clinical diagnosis combined with malignant ascites, and ascites drainage is not required within one week before the administration of the study.
- At least one measurable tumor lesion based on RECIST V1.1 criteria.
- ECOG PS ≤1.
- Expected survival ≥12 weeks.
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- Adequate organ function.
- Non-reproductive female patients, or reproductive female patients whose pregnancy test results are negative and commit to taking adequate and effective contraceptive measures or abstinence from the screening period until 3 months after the last administration, or male patients commit to taking adequate and effective contraceptive measures or abstinence from the screening period until 3 months after the last administration.
- Understands and provides written informed consent and willing to follow the requirements specified in protocol.
Who cannot join
- History of severe allergic reactions to protein drugs
- Have received NK cell therapy in the past.
- Untreated, unstable or uncontrolled central nervous system (CNS) metastases.
- Tumor invasion of vital arteries resulting in high risk of bleeding, significant risk of perforation or already formed fistulae.
- Major surgeries within 4 weeks before enrollment or are planned to undergo major surgeries during the trial (excluding exploration surgeries).
- New infections or concurrent infections occurred within 14 days before enrollment and have not yet been controlled to clinical stability.
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- Prior to the first study dose, systemic chemotherapy and anti-tumor monoclonal antibody drug therapy has been completed for at least 4 weeks; small molecule targeted drug therapy has been completed for at least 2 weeks or 5 half-lives of the drug (whichever is longer); intraperitoneal chemotherapy has been completed for at least 2 weeks; and treatment with proprietary Chinese medicines approved by the National Medicines and Pharmaceutical Administration (NMPA) as antitumor and having antitumor effects has been completed for at at least 2 weeks.
- Patients with severe respiratory disease at the time of screening that results in respiratory failure or who, in the judgment of the investigator, are not suitable for enrollment.
- Active autoimmune disease.except that the following are allowed to enter the screen: type I diabetes mellitus, hypothyroidism that can be controlled by replacement therapy only, and skin conditions (e.g., vitiligo, psoriasis, or alopecia areata) not requiring systemic therapy.
- Patients had severe cardiovascular disease at screening, with an acute cardiovascular event or pulmonary embolism within the last 6 months or vascular stenting within 6 months; or venous thrombotic disease, such as lower extremity venous thrombosis, within the last 1 month.
- Intestinal obstruction or gastrointestinal bleeding within 30 days prior to enrollment.
- Objective reasons for not being able to drain ascites adequately (including segregation of ascites) or in combination with coeliac ascites.
- Confirmed portal vein embolism or portal hypertension on examination.
- Active chronic hepatitis B, active hepatitis C, positive human immunodeficiency virus (HIV) antibodies or active syphilis infection.
- Combined with pleural effusion and causing clinical symptoms such as chest tightness and dyspnea, requiring clinical intervention as assessed by the investigator; or combined with moderate or greater amounts of pericardial effusion and clinical symptoms.
- Pregnant or lactating women.
- Subjects who, in the judgment of the investigator, have a history of other serious systemic disease or are unfit to participate in this trial for any other reason (the presence of psychiatric disorders, alcohol, drug, or substance abuse in the patient that may affect compliance with the trial, etc.)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-arm, Prospective, Open-label, Phase I/II Study of Allogeneic NK Cell Injection (SK-NK Injection) in the Treatment of Patients With Advanced or Metastatic Malignant Solid Tumors Accompanied by Malignant Ascites
This study is divided into two phases. Patients with recurrent or metastatic solid tumors accompanied by malignant ascites who have failed previous standard treatments are enrolled. The first phase is a single-arm, open-dose exploratory Phase I clinical study. In this phase, two dose groups are preset, namely 20×108 cells and 30×108 cells. Subjects who meet the inclusion criteria will receive intravenous infusion of SK-NK injection. Once a week for 6 consecutive infusions. After completing 6 consecutive infusions of SK-NK injection, the researchers evaluated that the patient benefited and could continue to receive 6 consecutive infusions of SK-NK injection. After completing 12 infusions, whether to continue the treatment subsequently could be determined based on the patient's condition. The second stage will be based on the results of the first stage to further verify the clinical efficacy, safety, tolerability and pharmacokinetic characteristics of RP2D, etc.
- Conditions
- Solid Tumor, Malignant Ascites
- Being tested
- SK-NK injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SK-NK injectionDrug
In this stage, two dose groups are preset, namely 20×108 cells and 30×108 cells. Subjects who meet the inclusion criteria will receive intravenous infusion of SK-NK injection once a week for six consecutive times. After completing six consecutive infusions of SK-NK injection, the researchers evaluated that the patient benefited and could continue to receive six consecutive infusions of SK-NK injection. After completing twelve infusions, the decision on whether to continue the treatment subsequently could be made based on the patient's condition
SK-NK injectionDrug
Based on the dose selected from the results of the first stage, the clinical efficacy, safety, tolerability and pharmacokinetic characteristics of RP2D were further verified. The types of cancer and the number of cases enrolled in stage II are to be determined
| Study group | Role | What they receive |
|---|---|---|
| Phase 1:Dose escalation stage | Experimental | "3+3" design. SK-NK injection, Two dose groups, namely 20×108 cells and 30×108 cells. Receives: Drug: SK-NK injection |
| Phase 2:Expansion stage | Experimental | The dose of SK-NK injection selected based on the results of the first stage Receives: Drug: SK-NK injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
SK-NK injection safety and tolerance
The incidence of DLT,TEAEs and SAE, and the safety indicators before and after administration
Measured: up to 12 months
ORR
Antitumor efficacy of SK-NK injection
Measured: up to 12 months
Secondary outcomes (7)
Pharmacokinetic (PK) characteristics of SK-NK injection;
To evaluate the Cmax of SK-NK injection in patients with advanced or metastatic malignant solid tumors accompanied by malignant ascites
Measured: up to 12 months
DCR
Disease control rate of SK-NK injection
Measured: up to 12 months
PFS
Progression-free survival of SK-NK injection
Measured: up to 12 months
OS
The overall survival of the enrolled patients
Measured: up to 12 months
Pharmacokinetic (PK) characteristics of SK-NK injection
To evaluate the t1/2 of SK-NK injection in patients with advanced or metastatic malignant solid tumors accompanied by malignant ascites
Measured: up to 12months
Pharmacokinetic (PK) characteristics of SK-NK injection;
To evaluate the Tmax of SK-NK injection in patients with advanced or metastatic malignant solid tumors accompanied by malignant ascites
Measured: up to 12months
Pharmacokinetic (PK) characteristics of SK-NK injection;
To evaluate the AUC0-last of SK-NK injection in patients with advanced or metastatic malignant solid tumors accompanied by malignant ascites
Measured: up to 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start30 May 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, Malignant AscitesStudies 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991478
- Sponsor's protocol ID
- SK-NK-001
- Status last verified
- May 2025
- First submitted
- 18 May 2025
- Last updated
- 28 May 2025
- 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 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Prospective, Open-label, Phase I/II Study of Allogeneic NK Cell Injection (SK-NK Injection) in the Treatment of Patients With Advanced or Metastatic Malignant Solid Tumors Accompanied by Malignant Ascites
- ClinicalTrials.gov ID
- NCT06991478
- Acronym / sponsor ID
- SK-NK-001
- Conditions
- Solid Tumor, Malignant Ascites
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 30 May 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 28 May 2025 (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.
This study is divided into two phases. Patients with recurrent or metastatic solid tumors accompanied by malignant ascites who have failed previous standard treatments are enrolled. The first phase is a single-arm, open-dose exploratory Phase I clinical study. In this phase, two dose groups are preset, namely 20×108 cells and 30×108 cells. Subjects who meet the inclusion criteria will receive intravenous infusion of SK-NK injection. Once a week for 6 consecutive infusions. After completing 6 consecutive infusions of SK-NK injection, the researchers evaluated that the patient benefited and could continue to receive 6 consecutive infusions of SK-NK injection. After completing 12 infusions, whether to continue the treatment subsequently could be determined based on the patient's condition. The second stage will be based on the results of the first stage to further verify the clinical efficacy, safety, tolerability and pharmacokinetic characteristics of RP2D, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1:Dose escalation stage | Experimental | Drug: SK-NK injection"3+3" design. SK-NK injection, Two dose groups, namely 20×108 cells and 30×108 cells. |
| Phase 2:Expansion stage | Experimental | Drug: SK-NK injectionThe dose of SK-NK injection selected based on the results of the first stage |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18 to 75 years.
- Malignant solid tumors confirmed by histology or pathology, including: advanced gastric cancer, colorectal cancer, esophageal squamous cell carcinoma, gynecological malignancies, etc. that have failed at least two lines of treatment.
- Pathological diagnosis or clinical diagnosis combined with malignant ascites, and ascites drainage is not required within one week before the administration of the study.
- At least one measurable tumor lesion based on RECIST V1.1 criteria.
- ECOG PS ≤1.
Key exclusion criteria (17 listed)
- History of severe allergic reactions to protein drugs
- Have received NK cell therapy in the past.
- Untreated, unstable or uncontrolled central nervous system (CNS) metastases.
- Tumor invasion of vital arteries resulting in high risk of bleeding, significant risk of perforation or already formed fistulae.
- Major surgeries within 4 weeks before enrollment or are planned to undergo major surgeries during the trial (excluding exploration surgeries).
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 |
|---|---|---|
| SK-NK injectionIn this stage, two dose groups are preset, namely 20×108 cells and 30×108 cells. Subjects who meet the inclusion criteria will receive intravenous infusion of SK-NK injection once a week for six consecutive times. After completing six consecutive infusions of SK-NK injection, the researchers evaluated that the patient benefited and could continue to receive six consecutive infusions of SK-NK injection. After completing twelve infusions, the decision on whether to continue the treatment subsequently could be made based on the patient's condition | Drug | Phase 1:Dose escalation stage |
| SK-NK injectionBased on the dose selected from the results of the first stage, the clinical efficacy, safety, tolerability and pharmacokinetic characteristics of RP2D were further verified. The types of cancer and the number of cases enrolled in stage II are to be determined | Drug | Phase 2:Expansion stage |
Primary outcome
SK-NK injection safety and tolerance
Time frame: up to 12 months
The incidence of DLT,TEAEs and SAE, and the safety indicators before and after administration
ORR
Time frame: up to 12 months
Antitumor efficacy of SK-NK injection
7 secondary outcomes
Pharmacokinetic (PK) characteristics of SK-NK injection;
Time frame: up to 12 months
DCR
Time frame: up to 12 months
PFS
Time frame: up to 12 months
OS
Time frame: up to 12 months
Pharmacokinetic (PK) characteristics of SK-NK injection
Time frame: up to 12months
Pharmacokinetic (PK) characteristics of SK-NK injection;
Time frame: up to 12months
Pharmacokinetic (PK) characteristics of SK-NK injection;
Time frame: up to 12months
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 28 May 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SK-NK injection in people with Solid Tumor, Malignant Ascites, run by Tianjin Medical University Cancer Institute and Hospital.
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 9 inclusion and 17 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: opening soon, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact TING DENG (15802243063, 18526812877@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SK-NK injection safety and tolerance (time frame: up to 12 months). The study lists 2 primary outcomes in all. 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 28 May 2025.