Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT02862704
Eligibility Criteria:
Inclusion Criteria:
* MG7 expression positive by histologically confirmed;
* Aged between 18 and 69;
* Persistent cancer after at least one prior standard of care chemotherapy, has no willing for surgery or cannot be suitable for surgery patients;
* Tumor is too big to surgical resection;
* Life expectancy greater than 4 months;
* Satisfactory organ and bone marrow function as defined by the following: (1) creatinine \<1.5mg/dl; (2) cardiac ejection fraction of \>55%; (3) hemoglobin\>9g/dl, bilirubin 2.0×the institution normal upper limit;
* Without bleeding disorder or coagulation disorders;
* Dont allergy to Radiocontrast agent;
* Birth control;
* Adequate venous access for apheresis, and no other contraindications for leukapheresis;
* Voluntary informed consent is given.
Exclusion Criteria:
* Pregnant or lactating women;
* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary;
* Patients in the situation of: (1) 30 days before apheresis is still in the period of other antitumor drug observation; (2) patient dont recuperate from earlier acute adverse influence brought by any treatments accepted before;
* Four weeks before recruit accepted radiation therapy;
* Previously treatment with any gene therapy products;
* Feasibility assessment during screening demonstrates\<30% transduction of target lymphocytes, or insufficient expansion (\<5-fold) in response to CD3/CD28 costimulation;
* Any serious, uncontrolled diseases (including, but not limit to, unstable angina pectoris, congestive heart failure, grade III or IV cardiac disease, serious arrhythmia, liver and kidney disorders or metabolic diseases, CNS diseases);
* Patient with severe acute hypersensitive reaction;
* Taking part in other clinical trials;
* Study leader considers not suitable for this tiral.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
69 Years
Study:
NCT02862704
Study Brief:
Protocol Section:
NCT02862704