New cell therapy takes on Hard-to-Treat cancers
NCT ID NCT07166263
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-phase trial will test NK510, a cell therapy, in 15 people with advanced stomach or colorectal cancer that has come back or not responded to at least two prior treatments. NK510 is given through an IV or directly into the abdomen. The main goals are to check safety and see if the treatment can shrink tumors or slow the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NK510 cell therapy
- What this could lead to
- If it works, this could point toward a new treatment option for advanced gastric and colorectal cancers that have not responded to other therapies.
- What could go wrong
- This is a very early, small trial with only 15 participants. The treatment may not work or could have serious side effects. Success in this phase does not guarantee broader 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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Early phase 1
The earliest testing in people: a first look at safety, in a very 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.
- Expected to start
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Nov 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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 years and older
- 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: 1. Aged ≥ 18 years, regardless of gender. 2. Gastric cancer and colorectal cancer that are inoperable and unresectable with radiotherapy: For gastric cancer, molecular diagnosis confirms that it is not AFP-producing gastric cancer. 3. Progressive disease or recurrence after receiving ≥ 2 lines of treatment. 4. Patients are divided into two groups (Group A and Group B) based on the presence or absence of peritoneal metastasis. The criteria for determining peritoneal metastasis are as follows: 1. Drained ascites ≥ 500ml, or B-ultrasound/CT in the supine position shows ascites depth ≥ 3cm. 2. Peritoneal metastasis confirmed by any of the following criteria: i. Positive for exfoliated cancer cells in ascites. ii. Diagnosed as peritoneal metastatic carcinoma by imaging and symptoms. iii. Peritoneal metastasis confirmed by abdominal exploration. iv. Ascites confirmed as exudate by routine ascites examination and ascites biochemistry. 5. At least one measurable lesion on CT or MRI according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumors). 6. ECOG performance status of 0-2. 7. Expected survival period ≥ 3 months. 8. Able to comply with the study protocol and follow-up procedures, and voluntarily sign the informed consent form for participation in this study. Exclusion Criteria: 1. Pregnant or lactating women. 2. Subjects with central nervous system (CNS) metastases and/or carcinomatous meningitis with obvious symptoms. 3. A history of other malignant tumors within the past 3 years. 4. Subjects with active, known or suspected autoimmune diseases \[excluding type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, or alopecia), or diseases that are not expected to relapse without external triggers\]. 5. Subjects with a history of immunodeficiency, including positive HIV test results, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation. 6. A history of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac rhythm or conduction abnormalities such as ventricular arrhythmias requiring clinical intervention, third-degree atrioventricular block, etc.; QTc interval \> 480 ms on 12-lead electrocardiogram at rest; acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events within 6 months before enrollment; New York Heart Association (NYHA) cardiac function classification ≥ class II or left ventricular ejection fraction (LVEF) \< 50%; clinically uncontrolled hypertension.
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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
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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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Nanjing Drum Tower Hospital, Affiliated to the Medical School of Nanjing University
Nanjing, Jiangsu, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gut bacteria may hold clues to why some cancer treatments work better
- Burning the edges: a new way to stop colon polyps from coming back
- Missed Follow-Up colonoscopies: do they raise the risk of advanced growths?
- A 2.2 mm scope could spot cancerous tissue in minutes, not days
- The gatekeepers of tumors: scientists probe how blood vessels let immune cells in
- New Antibody-Drug conjugate put to the test against Hard-to-Treat cancers