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 @ 3:24 PM
Ignite Modification Date:
2025-12-24 @ 3:24 PM
NCT ID:
NCT03423992
Eligibility Criteria:
Inclusion Criteria:
* Voluntary informed consent for entry of trial;
* Age greater than 18 years, and less than 70 years;
* Pathologically confirmed recurrent malignant gliomas;
* Tumor cells from resected tissue must be available for antigen testing (EGFRvIII, IL13Rα2, Her-2, CD133, EphA2, GD2) and at least one of the targets should be tested positively by immunohistochemistry study;
* If the patient is on dexamethasone, the anticipated dose must be 4 mg/day or less for at least 5 days prior to apheresis.
* Patients must have a Karnofsky performance status of greater than or equal to 70.
* Life expectancy greater than 3 months;
* Participants with adequate organ function as measured by:
1. White blood count greater than or equal to 2500/mm\^3; platelets greater than or equal to 100,000/mm\^3, hemoglobin greater than or equal to 10.0 g/dL; without transfusion or growth factor support
2. Aspartate transaminase (AST), Alanine transaminase (ALT), gamma glutamyl transpeptidase (GGT), lactic acid dehydrogenase (LDH), alkaline phosphatase within 2.5 x upper normal limit, and total bilirubin less than or equal to 2.0 mg/dL
3. Serum creatinine less than or equal to 1.5 x upper limit of normal
4. Coagulation tests prothrombin time (PT) and partial thromboplastin time (PTT) have to be within normal limits, unless the patient has been therapeutically anti-coagulated for previous venous thrombosis.
Exclusion Criteria:
* Female subjects of reproductive potential who are pregnant or lactating;
* Previous treatment with any gene therapy products or other form immunotherapy;
* Uncontrolled active infection.
* Active or latent chronic hepatitis B \[detectable hepatitis B surface antigen (HBsAg)\] or active hepatitis C (positive serology \[hepatitis C virus Ab\]) infection.
* HIV infection;
* History of allergy or hypersensitivity to study product excipients (human serum albumin, Dimethyl sulfoxide, and Dextran 40);
* Currently enrolled in other clinical trials;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03423992
Study Brief:
Protocol Section:
NCT03423992