Experimental cell therapy takes on solid tumors in early trial
NCT ID NCT07351903
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early study tests a new cell therapy called GK01, made from a patient's own immune cells, for advanced solid tumors. Fifteen participants will receive GK01 alone or with chemotherapy after surgery. The main goal is to check safety, not yet to prove it works.
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 (autologous tumor-reactive T cells)
- What this could lead to
- If it works, this could point toward a new cell-based treatment to control advanced solid tumors after surgery.
- What could go wrong
- This is a very early Phase 1 trial with only 15 people, so it is too soon to know if it works. The main goal is safety, not effectiveness.
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
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Feb 2029
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.
* Ability to understand and sign a written informed consent document. * At the date of signing ICF, 18 \~70 years old, male or female. * Patients with solid tumors confirmed by histopathology (including but not limited to pancreatic cancer, cholangiocarcinoma, gastric cancer, etc.) who are judged by investigator to be capable of undergoing radical total resection of the primary tumor for the purpose of cure. * No treatment for the primary tumor was received before surgical resection (no induction therapy or recurrent disease). * The expected survival time is more than 12 weeks;. * ECOG 0-1 points. Exclusion Criteria: * Inoperable or metastatic (Stage IV) solid tumors. * 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 solid 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. * Allergy to any components of the drugs planned. * Previous radiotherapy within 28 days before signing the ICF. * History of active tuberculosis infection within 1 year before screening. * 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. * Investigator-assessed clinically significant thyroid dysfunction. * Cardiovascular diseases with clinical significance. * No contraindications to curative resection of the primary tumor. * Attenuated or inactivated vaccines within 28 days before signing the I form, or planned administration of such vaccines during the screening period. * Comorbidities or other conditions are likely to affect protocol compliance or suitability 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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tianjin Cancer Hospital Airport Hospital
RECRUITINGTianjin, China
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