A Phase 1/2 interventional study of SK-NK injection and SK-NK injection in Solid Tumor, Malignant Ascites, sponsored by Tianjin Medical University Cancer Institute and Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-28.
Sponsored by Tianjin Medical University Cancer Institute and Hospital · Phase 1/2, Interventional, and Treatment
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.
247 studies on the registry are indexed under Ascites; 57 are open to participants now.
This study's planned enrollment of 10 is below the median of 54 across 179 interventional studies indexed under Ascites.
Browse Ascites studies →Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 494 studies on the registry; 293 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
"3+3" design. SK-NK injection, Two dose groups, namely 20×108 cells and 30×108 cells.
Drug: SK-NK injection
The dose of SK-NK injection selected based on the results of the first stage
Drug: SK-NK injection
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
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
SK-NK injection safety and tolerance
The incidence of DLT,TEAEs and SAE, and the safety indicators before and after administration
Time frame: up to 12 months
ORR
Antitumor efficacy of SK-NK injection
Time frame: up to 12 months
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
Time frame: up to 12 months
DCR
Disease control rate of SK-NK injection
Time frame: up to 12 months
PFS
Progression-free survival of SK-NK injection
Time frame: up to 12 months
OS
The overall survival of the enrolled patients
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: up to 12months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2025; primary completion for May 2026, 12 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Tianjin Medical University Cancer Institute and Hospital →