Safety and Efficacy of CEA-Targeted CAR-T Therapy for Relapsed/Refractory CEA+ Cancer
NCT ID: NCT04348643
Last Updated: 2023-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2020-02-20
2024-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of CEA-targeted CAR-T for CEA-positive Advanced Malignant Solid Tumors
NCT05538195
A Clinical Research of CAR T Cells Targeting CEA Positive Cancer
NCT02349724
Study of CEA Targeting CAR-T (PTC13) in the Treatment of CEA-Positive Advanced Malignant Solid Tumors
NCT06821048
CEA-Targeted CAR-T Therapy in CEA-Positive Advanced Solid Tumors
NCT07179692
A Clinical Study of CEA-targeted CAR-T in the Treatment of CEA-positive Advanced Malignant Solid Tumors
NCT05396300
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CEA+ CAR-T
CAR-T cell reinfusion is carried out in 1\~3 times
CEA CAR-T cells
CEA-CAR-T cells will be administered intravenously.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CEA CAR-T cells
CEA-CAR-T cells will be administered intravenously.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chongqing Precision Biotech Co., Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Henan Cancer Hospital
Henan, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PBC017
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.