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New cell therapy takes on Hard-to-Treat cancers

NCT ID NCT07166263

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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.

    Open the record ↗

  3. 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

  • 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.