Engineered immune cells take on Hard-to-Treat cancers
NCT ID NCT05396300
First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times
Summary
This early-stage trial tests a treatment called Anti-CEA CAR-T, which uses a patient's own immune cells modified to recognize and attack cancer cells that carry a protein called CEA. The study enrolls about 110 adults with advanced colorectal, gastric, or other solid tumors that have not responded to at least two prior treatments. The main goals are to check safety and find the best dose.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Anti-CEA CAR-T cells (a type of immune cell therapy)
- What this could lead to
- If it works, this could point toward a new treatment option for advanced solid tumors that have not responded to standard therapies.
- What could go wrong
- This is an early Phase 1 trial focused on safety and dosing, so it is too soon to know if it will be effective. There are also risks of serious side effects from the chemotherapy given before the cell infusion.
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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58 people
The number who actually took part.
- Started
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May 2022
- Finished
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Jun 2026
- 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 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. Age ≥18 years old, male or female; 2. Advanced, metastatic or recurrent malignant tumors diagnosed by histology or pathology, mainly colorectal cancer; 3. After receiving at least second-line standard treatment and failing (disease progression or intolerance, such as surgery, chemotherapy, radiotherapy, etc.) or lack of effective treatment methods; 4. Immunohistochemical staining of tumor samples within 3 months confirmed that the tumor was CEA positive (clear membrane staining, positive rate ≥ 10%); If over 3 months, the patient's serum CEA should exceed 10ug/L. 5. At least one assessable lesion according to RECIST 1.1 criteria; 6. ECOG score 0-2 points; 7. No serious mental disorder; 8. Unless otherwise specified, the function of the vital organs of the subject shall meet the following conditions: 1. Blood routine: white blood cells\>2.0×109/L, neutrophils\>0.8×109/L, lymphocytes cells\>0.5×109/L, platelets\>50×109/L, hemoglobin\>90g/L; 2. Cardiac function: echocardiography showed cardiac ejection fraction ≥50%, and no obvious abnormality was found on electrocardiogram; 3. Renal function: serum creatinine≤2.0×ULN; 4. Liver function: ALT and AST ≤3.0×ULN (for those with liver tumor infiltration, it can be relaxed to≤5.0×ULN); 5. Total bilirubin≤2.0×ULN; 6. Oxygen saturation \> 92% in non-oxygen state. 9. Have apheresis or venous blood collection standards, and have no other contraindications for cell collection; 10. Subjects agree to use reliable and effective contraceptive methods for contraception within 1 year after signing the informed consent form to receiving CAR-T cell infusion (excluding rhythm contraception); 11. The patients themselves or their guardians agree to participate in this clinical trial and sign the ICF, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the research. Exclusion Criteria: 1. CNS metastases or meningeal metastases with clinical symptoms at the time of screening, or there is other evidence that the patient's central nervous system metastases or meningeal metastases have not been controlled, and are judged by the investigator to be unsuitable for inclusion; 2. Participated in other clinical studies within 1 month before screening; 3. vaccinated with live attenuated vaccine within 4 weeks before screening; 4. Received the following anti-tumor treatments before screening: Received chemotherapy, targeted therapy or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter); 5. Active infection or uncontrollable infection requiring systemic treatment; 6. Patients with intestinal obstruction, active gastrointestinal bleeding, or a history of gastrointestinal bleeding within 3 months; 7. Except for alopecia or peripheral neuropathy, the toxicity of previous anti-tumor therapy has not improved to the baseline level or ≤ grade 1; 8. Suffering from any of the following heart diseases: 1. New York Heart Association (NYHA) stage III or IV congestive heart failure; 2. Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months before enrollment; 3. Clinically significant ventricular arrhythmia, or history of syncope of unknown origin (caused by vasovagal except those caused by neurosis or dehydration); 4. History of severe non-ischemic cardiomyopathy; 9. Patients with active autoimmune disease, or other patients requiring long-term immunosuppressive therapy; 10. Suffering from other uncured malignant tumors in the past 3 years or at the same time, except cervical carcinoma in situ and basal cell carcinoma of the skin; 11. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer is greater than the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Virus (HCV) RNA test is greater than the normal range; human immunodeficiency virus (HIV) antibody positive; syphilis test positive; 12. Women who are pregnant or breastfeeding; 13. Other investigators deem it unsuitable to participate in the study.
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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.
Contacts and locations
Locations
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First affiliated hospital, Zhejiang University
Hangzhou, Zhejiang, 310006, China
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