Recruiting

Testing immune cells targeting cancer in advanced solid tumors

Plain-English translation of NCT05396300 on ClinicalTrials.gov ↗ · Source last updated April 2026 · Translation generated June 2026 · How we translate trials

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Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

This trial is testing a new immunotherapy called anti-CEA CAR-T therapy, which uses your own immune cells that have been specially engineered in a lab to recognize and attack cancer cells. The cells are infused back into your body through different methods—some patients receive them through an IV, while others receive them directly into the abdomen. Researchers are testing different doses to find the safest and most effective amount.

Advanced solid cancers like colorectal and gastric cancer often resist standard treatments like chemotherapy and surgery. This new treatment aims to give patients whose cancers have progressed a different option by using their own immune system to fight back.

Do you qualify?

You likely qualify if…

you are 18 years or older
you have been diagnosed with advanced colorectal, gastric, or other solid cancer that has spread or come back
your cancer has failed at least two standard treatments (chemotherapy, surgery, radiation, or other options) or you cannot tolerate them
your tumor has been confirmed to have the CEA marker through a recent biopsy or blood test
you have acceptable heart, kidney, liver, and bone marrow function based on recent blood work and heart imaging
you are able to have blood cells collected and are willing to use reliable birth control for one year after treatment

You likely don't qualify if…

you have cancer that has spread to your brain or spinal cord causing symptoms
you were vaccinated with a live vaccine in the past 4 weeks
you received chemotherapy, targeted therapy, or other experimental drugs within 2 weeks before screening
you have an active, uncontrolled infection requiring antibiotics or other treatment
you have bowel obstruction, active bleeding in your stomach or intestines, or recent gastrointestinal bleeding in the past 3 months

What participation looks like

If you qualify, your blood will be collected to harvest immune cells, which are then sent to a laboratory to be engineered with the CAR-T modification. After a few weeks, you will return to receive an infusion of these modified cells—either through an IV into your bloodstream or directly into your abdomen, depending on which treatment group you are assigned to. You will then be monitored closely with blood tests, imaging scans, and clinic visits to see how your body responds to the treatment and whether your cancer improves.

AI-generated summary from trial data · Jun 3, 2026 · Not medical advice

Trial locations(1 site)

China

First affiliated hospital, Zhejiang University, Hangzhou, Zhejiang