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 @ 9:23 PM
Ignite Modification Date:
2025-12-24 @ 9:23 PM
NCT ID:
NCT06815432
Eligibility Criteria:
Procurement Inclusion Criteria:
* Diagnosis of GPC3-positive recurrent glioblastoma with previous resection planned for repeat resection.
* Age ≥18 years
* Karnofsky score ≥60%
* Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent
* GPC3 expression (as determined by immunohistochemistry) with an extent score of ≥ Grade 2 (\>25% positive tumor cells) and an intensity score of ≥ 2 (scale 0-4).
Procurement Exclusion Criteria:
* History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment (only patients who have received prior therapy with murine antibodies).
* History of organ transplantation
* Known HIV positivity
* Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections).
* Exhibits other risk factors of which administration of investigational agent is deemed not in the patient's best interest, in the opinion of the investigator
Treatment Inclusion Criteria:
* Age ≥ 18 years
* Diagnosis of recurrent glioblastoma with previous resection
* Karnofsky score ≥ 60%-
* Stable neurologic exam for 7 days prior to enrollment
* Stable or decreasing dose of steroids over past 7 days prior to surgery and administration of therapy (max allowable dose is 0.1mg/kg dexamethasone or equivalent per day)
* Adequate organ function:
* Creatinine clearance as estimated by Cockcroft Gault or Schwartz ≥ 60 ml/min
* total bilirubin \< 3 times ULN for age
* INR ≤1.7
* absolute neutrophil count \> 500/μl
* platelet count \> 100,000/μl (can be transfused but must be achieved prior to enrollment)
* Hgb ≥ 7.0 g/dl (can be transfused)
* Pulse oximetry \>90% on room air
* Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study
* Sexually active patients must be willing to utilize one of the more effective birth control methods for 3 months after the T-cell infusion.
* Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
Treatment Exclusion Criteria:
* Pregnancy or lactation
* Uncontrolled infection
* Known HIV positivity
* Active bacterial, fungal or viral infection
* History of organ transplantation
* History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment (only patients who have received prior therapy with murine antibodies)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT06815432
Study Brief:
Protocol Section:
NCT06815432