Safety and Efficacy of CEA-Targeted CAR-T Therapy for Relapsed/Refractory CEA+ Cancer (NCT04348643) | Clinical Trial Compass
WithdrawnPhase 1/2
Safety and Efficacy of CEA-Targeted CAR-T Therapy for Relapsed/Refractory CEA+ Cancer
Stopped: The sponsor requested to terminate the study.
China0Started 2020-02-20
Plain-language summary
This is a single arm study to evaluate the efficacy and safety of CEA-targeted CAR-T cells therapy for patients with relapsed/refractory CEA+ Cancer,and obtain the recommended dose and infusion plan.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. No gender limitation, age 18-75 years old (including boundary value);
. 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);
. There are measurable and assessable lesions: the diameter of the lesion under CT or MRI scan is greater than 0.5cm;
. The expected survival time is more than 12 weeks;
. KPS≥60 ;
. No serious mental disorders;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Have received CAR-T treatment or other genetically modified cell treatment before screening;
. Participated in other clinical studies within 1 month before screening;
. 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;
. Have received live attenuated vaccine within 4 weeks before screening;
. Cerebrovascular accident or seizure occurred within 6 months before signing the ICF;
. Suffering from any of the following heart diseases:
. New York Heart Association (NYHA) stage III or IV congestive heart failure;
. Myocardial infarction occurred or received coronary artery bypass graft (CABG) ≤6 months before enrollment;