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:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT04489420
Eligibility Criteria:
Inclusion Criteria:
1. Histologically confirmed glioblastoma multiforme (GBM) and are at first or second relapse.
2. ≥ 18 years of age
3. Have measurable disease of at least one solitary lesion with a dimension between 1 cm and 5 cm according to RANO
4. Karnofsky performance status (KPS) ≥ 60
5. Adequate organ function defined by laboratory values as follows: Creatinine \< 140 µmol/L (1.6 mg/dL); if borderline, the creatinine clearance ≥40 mL/min, Bilirubin \< 20% above the upper limit of normal, AST and ALT ≤ 2.5 the upper limit of normal.
6. Absolute Neutrophil count baseline (ANC) ≥1500 cells/uL, Hemoglobin baseline ≥ 9.0 g/dL and Platelets baseline ≥ 100,000 cells/uL prior to the start of study treatment.
7. Female of childbearing potential (FCBP) must not be pregnant and agree to not becoming pregnant for at least 42 days following the start of the treatment.
8. Patients with HIV/AIDs are eligible if they have not had an opportunistic infection within the past 12 months
9. Patients with chronic HBV infection or patients with current or a history of HCV infection are allowed if:
1. have an HBV viral load below the limit of quantification and be on viral suppressive therapy
2. have current HCV infection, they should be on concurrent HCV treatment and the HCV viral load must be below the limit of quantification
3. have a history of HCV infection should have completed curative antiviral treatment and require HCV viral load below the limit of quantification
Exclusion Criteria:
1. Had prior radiation therapy within 12 weeks of screening MRI unless there is unequivocal histological confirmation of tumor progression
2. Subjects on growth factors therapy with less than 4 weeks washout period (for short-acting growth factors, such as G-CSF, GM-CSF 5-day wash-out for longer-acting factors (such as Neulasta) 10 days
3. Radiotherapy, chemotherapy, or other investigational agents within 4 weeks
4. Prior cellular or gene therapy at any time
5. Clinical or laboratory signs for immunodeficiency or under immunosuppressive medication or steroids greater than15 mg prednisone or equivalent per day
6. History of malignancy, other than GBM, unless the subject has been free of disease for \> 3 years from the date of signing the ICF. Exceptions include the following noninvasive malignancies: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
7. Active autoimmune disease other than controlled connective tissue disorder or those who are not on active therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04489420
Study Brief:
Protocol Section:
NCT04489420