Clinical Trial Details
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NCT02937844 : Pilot Study of Autologous Chimeric Switch Receptor Modified T Cells in Recurrent Glioblastoma Multiforme
PhasePhase 1
AgesMin: 18 Years Max: 70 Years
Inclusion Criteria:

1. abilities to understand and the willingness to provide written informed consent;

2. patients are = 18 and = 70 years old;

3. recurrent glioblastoma 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;

4. Malignant cells are PD-L1 positive confirmed by IHC;

5. karnofsky performance score (KPS) = 60;

6. life expectancy >3 months;

7. 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;

8. peripheral blood absolute lymphocyte count must be above 0.8×10^9/L;

9. satisfactory heart functions;

10. patients must be willing to follow the orders of doctors;

11. 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.

Exclusion Criteria:

1. a prior history of gliadel implantation 4 weeks before this study start or antibody
based therapies;

2. HIV positive;

3. hepatitis B infection or hepatitis C infection;

4. history of autoimmune disease, or other diseases require long-term administration of
steroids or immunosuppressive therapies;

5. history of allergic disease, or allergy to CAR T cells or study product excipients;

6. patients already enrolled in other clinical study;

7. patients, in the opinion of investigators, may not be eligible or not able to comply
with the study.
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