Engineered immune cells take aim at multiple Hard-to-Treat cancers
NCT ID NCT04348643
First seen Jul 10, 2026 · Last updated Jul 10, 2026
Summary
This study tests a therapy called CEA CAR-T, which uses a patient's own immune cells modified to recognize and attack cancer cells that carry a protein called CEA. It is for adults aged 18-75 with advanced or recurrent solid tumors (such as lung, colorectal, liver, pancreatic, gastric, or breast cancer) that have not responded to standard treatments. The goal is to see if this cell therapy is safe and effective, and to find the best dose and schedule.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CEA CAR-T cells
- What this could lead to
- If successful, this could offer a new treatment option for several hard-to-treat cancers that express CEA, potentially shrinking tumors or slowing disease progression.
- What could go wrong
- This is an early-phase trial (Phase 1/2) with a small number of participants, so the therapy may not work for everyone. CAR-T therapy can also cause serious side effects like cytokine release syndrome.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Expected to start
-
Feb 2020
An estimate. Start dates often move.
- Expected to finish
-
Apr 2024
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 to 75 years
- Sex
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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 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. No gender limitation, age 18-75 years old (including boundary value); 2. Late, metastatic, or recurrent malignant tumors that have received at least first-line standard treatment failure (progressive or intolerable disease, such as surgery, chemotherapy, radiotherapy, targeted therapy, etc.) or lack effective treatment, and the tumor CEA positive expression (tumor CEA positive or serum CEA level\> 50ng / ml confirmed by histology or pathology); 3. There are measurable and assessable lesions: the diameter of the lesion under CT or MRI scan is greater than 0.5cm; 4. The expected survival time is more than 12 weeks; 5. KPS≥60 ; 6. No serious mental disorders; 7. The functions of important organs are basically normal: 1. Blood routine: white blood cells\> 2.0 × 10\^9 / L, neutrophils\> 0.8 × 10\^9 / L, lymphocytes\> 0.5 × 10\^9 / L, platelets\> 50 × 10\^9 / L, hemoglobin\> 90g / L; 2. Cardiac function: cardiac ultrasound indicates that the cardiac ejection fraction is ≥50%, and there is no obvious abnormality on the electrocardiogram; 3. Renal function: serum creatinine and urea nitrogen ≤3.0 × ULN; 4. Liver function: ALT and AST ≤5.0 × ULN; total bilirubin ≤3.0 × ULN; 5. Blood oxygen saturation\> 92%. 8. There are no other serious diseases that conflict with this plan (such as autoimmune diseases, immunodeficiency, organ transplantation); 9. There are no contraindications for apheresis or intravenous blood collection or other cell collection; 10. The patient or his guardian agrees to participate in this clinical trial and sign the ICF, indicating that he understands the purpose and procedures of this clinical trial and is willing to participate in the study. Exclusion Criteria: 1. Have received CAR-T treatment or other genetically modified cell treatment before screening; 2. Participated in other clinical studies within 1 month before screening; 3. Received the following anti-tumor treatment before screening: received chemotherapy, targeted therapy or other experimental drug treatment within 4 weeks, except for those who have confirmed disease progression after treatment; 4. Have received live attenuated vaccine within 4 weeks before screening; 5. Cerebrovascular accident or seizure occurred within 6 months before signing the ICF; 6. Suffering from any of the following heart diseases: 1. New York Heart Association (NYHA) stage III or IV congestive heart failure; 2. Myocardial infarction occurred or received coronary artery bypass graft (CABG) ≤6 months before enrollment; 3. Clinically significant ventricular arrhythmias, or history of syncope of unknown cause (except for conditions caused by vasovagal or dehydration); 4. Severe cardiac insufficiency, severe heart valve disease and other cardiovascular system diseases; 7. There are active infections or uncontrollable infections requiring systemic treatment within 2 weeks before screening; 8. Active autoimmune diseases; 9. Suffering from chronic enteritis and / or intestinal obstruction; 10. Suffering from other malignant tumors, in addition to fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and ductal carcinoma in situ after radical resection; 11. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection 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. The situation that other researchers think is not suitable for participating 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
-
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
-
Henan Cancer Hospital
Henan, China
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Other studies related to the condition(s) this trial covers.
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