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|NCT03347097 : PD1-PIK Cell Therapy for Patients With Glioblastoma Multiforme|
|Phase||Early Phase 1|
|Ages||Min: 18 Years Max: 70 Years|
1. Patients with histologically confirmed brain glioblastoma multiforme.
2. Patients with maximum safe resection of the tumor (=95%) confirmed with contrast MR
within 72 hours after surgery.
3. Age from 18 to 70 years.
4. Karnofsky performance score = 60.
5. Adequate organ function within 14 days of study registration including the following:
Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count, (ANC) =
1.0×10^9/L, platelets =100×10^9/L; hemoglobin = 9 g/dL. Hepatic: bilirubin =1.3 mg/dL
or 0-22 mmol/L, aspartate transaminase (AST) and alanine transaminase (ALT) < 3×upper
limit of normal (ULN). Renal: Normal serum Creatinine for age (below) or creatinine
clearance >60 ml/min/1.73 m2. Electrocardiogram: normal.
6. Written informed consent must be obtained from all patients.
1. Pregnant or breast-feeding patients. Pregnancy testing will be performed on all
menstruating females within 14 days of study enrollment.
Patients with uncontrolled intercurrent illness including, but not limited to ongoing
or active infection, symptomatic congestive heart failure, unstable angina pectoris,
or psychiatric illness/social situations that would limit compliance with study
2. Patients with history of immune system abnormalities such as hyperimmunity (e.g.,
autoimmune diseases) and hypoimmunity (e.g., myelodysplastic disorders, marrow
failures, AIDS, ongoing pregnancy, transplant immuno-suppression), or medication of
3. Patients with any conditions that could potentially alter immune function (e.g., AIDS,
multiple sclerosis, diabetes, renal failure).
Patients currently received any other investigational agents.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03347097
| Link to official Clinicaltrials.gov listing