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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT05685004
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed MGMT unmethylated glioblastoma multiforme (no prior treatment)
* Sufficient cancer tissue obtained to allow for manufacture of autologous cancer cell vaccines
* The attenuated autologous cancer cell product generated has satisfied the product release criteria as determined by the sponsor quality control department
* Medical history, physical examination and laboratory testing performed within approximately 7 days before enrollment revealing kidney and liver organ function within normal limits
* not currently receiving glucocorticoids and have been off glucocorticoids for at least 24 hours prior to vaccination as well as when they receive the T cell infusion.
* Patient function assessment (Karnofsky score is \> 60)
* a life expectancy of \> 12 weeks.
* Hemoglobin is \> 10 g/dL (may be transfused)
* White blood cell count is \> 3,000 cells/microliter (mcL) of blood.
* Platelet count is \> 100,000 platelets per mcL of blood (transfusion independent)
* Lymphocyte count is \> 1,000 cells/mcL of blood.
Exclusion Criteria:
* another concomitant life-threatening disease (not including glioblastoma multiforme)
* a second malignancy that is not in remission as determined by the clinical investigator. Exception: squamous or basal cell carcinoma of the skin.
* requirement for treatment with glucocorticoids to control brain swelling
* presence of active autoimmune disease that is currently being actively treated.
* psychological, familial, sociological or geographical conditions that do not permit adequate medical follow-up and compliance with the study protocol.
* Current pregnancy or a plan to become pregnant within 1-year following the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05685004
Study Brief:
Protocol Section:
NCT05685004