Immunogene-modified T (IgT) Cells Against Glioblastoma Multiforme
- Trial number:
- NCT03170141
- Trial phase:
- 1
- Study type:
- Immunotherapy, Supportive interventions
- Overall status:
- Enrolling by invitation
Study start date
Scientific title
Summary
abilities to understand and the willingness to provide written informed consent;patients are ≥ 1 and ≤ 80 years old; recurrent glioblastoma or brain tumor patients with measurable tumors. Patients have received standard care of medication, such as gross total resection with concurrent radio-chemotherapy (~54 - 60 Gy, TMZ). Patients must either not be receiving dexamethasone or receiving ≤ 4 mg/day at the time of leukopheresis; Malignant cells are target antigen positive confirmed by immunostaining, quantitative PCR or sequencing; karnofsky performance score (KPS) ≥ 60; life expectancy >3 months; satisfactory bone marrow, liver and kidney functions as defined by the following: absolute neutrophile count ≥ 1500/mm^3; hemoglobin > 10 g/dL; platelets > 100000 /mm^3; Bilirubin < 1.5×ULN; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5×ULN; creatinine < 1.5×ULN; peripheral blood absolute lymphocyte count must be above 0.8×10^9/L; satisfactory heart functions; patients must be willing to follow the orders of doctors; women of reproductive potential (between 15 and 49 years old) must have a negative pregnancy test within 7 days of study start. Male and female patients of reproductive potential must agree to use birth control during the study and 3 months post study.