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 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
NCT ID:
NCT03914768
Eligibility Criteria:
Inclusion Criteria:
1. Abilities to understand and the willingness to provide written informed consent. Assent will be obtained when appropriate based on the subjects age;
2. Patients are ≥ 6 months and ≤ 80 years old;
3. DIPG or GBM patients with existing or measurable tumors in the brain. Patients have received standard care of medication, such as gross total resection with concurrent radio chemotherapy (\~54 - 60 Gy, TMZ);
4. Patients with adequate neurological function and epileptic symptoms that are well controlled;
5. Observing the condition after surgery or without surgery;
6. Karnofsky performance score (KPS) ≥ 60;Life expectancy \>3 months;
7. Important organ function is satisfied: Cardiac ultrasound indicates a cardiac ejection fraction ≥50%; and there is no obvious abnormality in the electrocardiogram; blood oxygen saturation ≥90%; creatinine \<2.5 times normal range; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 3 times normal range; Total bilirubin ≤ 2.0 mg / dl; Hgb (hemoglobin) ≥ 80g / L;
8. Peripheral blood absolute lymphocyte count must be above 0.8×10\^9/L;
9. Adequate Neurologic Function Defined as: Patients with seizure disorder may be enrolled if seizure disorder is well controlled;
10. Patients must be willing to follow the orders of doctors.
Exclusion Criteria:
1. A prior history of gliadel implantation 4 weeks before this study start or antibody based therapies;
2. The patient was still using dexamethasone at a dose greater than 4 mg/day during mononuclear cell collection;
3. Patients have a history of autoimmune diseases or other diseases requiring long-term use of hormones or immunosuppressive drugs;
4. Patients with a history of allergies or allergies to immune cells and adjuvants of cellular products;
5. Active infection with fever;
6. Patients with neutropenia (\> 10 days) that are difficult to correct after treatment;
7. Infection with bacteria, fungi or viruses, uncontrolled;
8. Patients with HIV and those living with active HBV and HCV;
9. Pregnant, pregnant and lactating women;
10. Important organ failure (heart, liver, kidney, lung);
11. Patients who had previously been treated with cell therapy but were ineffective after physical examination were discussed and confirmed by team experts and were not suitable for re-treatment;
12. Anything that researchers believe may increase the risk of subjects or interfere with test results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
75 Years
Study:
NCT03914768
Study Brief:
Protocol Section:
NCT03914768