Experimental cell combo takes on advanced cancers in early trial
NCT ID NCT07407985
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial is testing a new cell therapy called GK01 combined with a PD-1 immune checkpoint inhibitor in 15 people with advanced solid tumors (such as lung, stomach, or colorectal cancer). The main goal is to see if the combination is safe and tolerable, while also checking how long it stays in the body and whether it shows any signs of shrinking tumors. Because this is a Phase 1 study, it is too soon to know if the treatment will work, and the focus is on safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GK01 cell injection combined with a PD-1 monoclonal antibody
- What this could lead to
- If it works, this could point toward a new combination treatment for advanced solid tumors that helps the immune system fight cancer more effectively.
- What could go wrong
- This is a very early Phase 1 trial with only 15 participants, so it is primarily testing safety, not effectiveness. The treatment may not shrink tumors or improve survival, and side effects could be serious.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Informed Consent Form (ICF) . * Aged 18 to 70 years (inclusive) at the time of signing the ICF. * Histologically or cytologically confirmed advanced solid tumors that are metastatic or locally recurrent (including but not limited to small cell lung cancer, non-small cell lung cancer, gastric cancer, colorectal cancer, etc.); * ECOG score of 0 \~1 . * Expected survival time is more than 12 weeks. * Negative blood pregnancy test for females of childbearing potential is required. Exclusion Criteria: * Patients with central nervous system (CNS) metastasis, leptomeningeal disease, or metastatic spinal cord compression; or a history of CNS disorders, including but not limited to epilepsy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, etc. * History of bone marrow or organ transplantation; * History of other primary malignancies within 5 years prior to study treatment * Hepatitis B surface antigen (HBsAg) positivity; With negative HBsAg but positive hepatitis B core antibody (HBcAb) ,and if peripheral blood hepatitis B virus (HBV) DNA positive; Hepatitis C virus (HCV) antibody positive and HCV RNA positive; Human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive; Both Treponema pallidum-specific and non-specific antibody tests are positive. * Patients with a known allergy to any component of the study drugs. * Received treatment with anti-PD-1, anti-PD-L1 therapeutic antibodies, or drugs targeting this pathway. * Received any investigational drug or systemic anticancer therapy within 28 days before infusion (or 5 half-lives of the drug, whichever is considered more appropriate by the investigator). * Received wide-field radiotherapy within 28 days prior to signing the ICF, with the exception of palliative radiotherapy to non-target lesions for symptom relief, administered at least 14 days before signing the ICF or planned during the study period. * Undergone major surgery within 28 days prior to signing the ICF, or are scheduled to undergo major surgery during the study period. * At the time of signing the ICF, any toxicity from prior anti-cancer therapy (except alopecia and pigmentation) that has not recovered to Grade 1 (excluding lymphocytopenia) or to baseline level (according to NCI CTCAE version 5.0). * Any uncontrolled active infection requiring parenteral (IV) antibiotic, antiviral, or antifungal treatment at the time of signing the ICF or within 4 weeks before the first infusion. * History of active tuberculosis infection within 1 year prior to screening (subjects with a history of active tuberculosis infection more than 1 year ago are eligible if, in the investigator's judgment, there is no current evidence of active tuberculosis). * Concurrent or previous history of interstitial lung disease or interstitial pneumonia; presence of chronic lung disease or other respiratory conditions that significantly impair lung function. * Diagnosis of active autoimmune disease or a history of autoimmune disease that may recur (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, psoriasis, etc.), or at risk of such conditions. * Required treatment with systemic corticosteroids (at a dose equivalent to or higher than 10 mg/day of prednisone) or other immunosuppressive medications within 2 weeks before signing the ICF or during the study period. * Clinically significant thyroid dysfunction as assessed by the investigator. * Clinically significant cardiovascular diseases. * Insufficient bone marrow reserve or insufficient organ function. * Bleeding within 6 months before signing the ICF; clinically significant bleeding requiring medical intervention within 28 days before screening, including esophageal variceal bleeding. * Poorly controlled pleural, peritoneal, or pericardial effusion during the screening period (e.g., presence of clinical symptoms, fluctuating volume, requiring repeated drainage, or the use of oral diuretics). Presence of ascites detectable on physical examination, clinical symptoms caused by ascites, or the need for special management such as repeated drainage or intraperitoneal drug infusion (subjects with only a small amount of ascites detectable solely via imaging may be considered for enrollment). * Administration of attenuated or inactivated vaccines within 28 days before signing the ICF, or planned administration of such vaccines during the screening period. * The investigator considers that the subject's complications or other conditions may affect compliance with the protocol or that the subject is unsuitable for participation in this study. * Female subjects who are pregnant or breastfeeding.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Tianjin Cancer Hospital Airport Hospital
Tianjin, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Oral drug RVU120 put to the test against advanced solid tumors