New CAR-NK cell therapy takes on colorectal cancer
NCT ID NCT07462650
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new treatment made from donated cord blood cells that are engineered to recognize and attack colorectal cancer cells. It is for people with advanced or metastatic colorectal cancer that has not responded to standard treatments. The trial will check safety and early signs of effectiveness in 48 adults.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Allogeneic dual-target CAR-NK cells (engineered immune cells from donated cord blood) targeting CEA and/or GUCY2C, with an IL-15 support element and a safety switch
- What this could lead to
- If successful, this could point toward a new treatment option for advanced colorectal cancer that has stopped responding to standard therapies.
- What could go wrong
- This is an early phase 1/2 trial with only 48 participants, so results may not apply broadly. The treatment involves genetically modified cells, which could cause unexpected side effects or fail to control the cancer.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Dec 2028
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 to 75 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: * Histologically confirmed colorectal adenocarcinoma that is unresectable or metastatic and has progressed after, is intolerant to, or is ineligible for standard therapies. * Measurable disease per RECIST v1.1 (unless in minimal residual disease (MRD) or post-resection cohorts if a future amendment is planned). * Tumor antigen co-expression meeting central lab thresholds for one of the following pairs: CEA+GUCY2C, CEA+HER2, or GUCY2C+HER2. * ECOG performance status 0-1. * Adequate organ function (hematologic, renal, hepatic, and cardiac) as defined in protocol. * Recovered to Grade \<=1 from prior therapy-related toxicities (except stable Grade 2 neuropathy or alopecia). * Life expectancy \>= 12 weeks. * Willingness to use effective contraception during study and for a protocol-defined period after cell infusion. Exclusion Criteria: * Active, uncontrolled infection (including uncontrolled HBV/HCV) or known uncontrolled HIV infection. * Active CNS metastases that are symptomatic or require escalating steroids. (Stable treated CNS disease may be allowed per protocol.) * Prior gene-modified cellular therapy (CAR-T/CAR-NK/TCR-T) within 6 months, or any prior therapy that in the investigator's judgment increases risk of severe toxicity. * Clinically significant autoimmune disease requiring systemic immunosuppression within the past 6 months. * Concurrent anti-cancer therapy (other than protocol-permitted bridging) during the DLT window. * Pregnant or breastfeeding. * Significant cardiovascular disease (e.g., recent MI, uncontrolled arrhythmia), uncontrolled pulmonary disease, or other severe comorbidity that would increase risk. * Known hypersensitivity to study chemotherapy components (fludarabine/cyclophosphamide) or required supportive medications. * Any condition that, in the investigator's opinion, would interfere with study participation, safety monitoring, or interpretation of results.
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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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Peking University Shenzhen Hospital
RECRUITINGShenzhen, Guangdong, 518036, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a vaccine boost immunotherapy against a stubborn cancer?
- What does recovery really look like after aggressive peritoneal cancer surgery?