This study will evaluate the safety of PD-1 knockout EBV-CTL cells in treating EBV (Epstein-Barr virus) positive advanced stage malignancies. Blood samples will also be collected for research purposes.
This is a study of CRISPR-Cas9 mediated PD-1 knockout-T cells from autologous origin. Patients are assigned to receive 4 circles of cell therapy. The safety and clinical response are evaluated. Biomarkers and immunological markers are also monitored.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
To modify immune micro-environment
To modify immune micro-environment
To sustain the survival of infused T cells
The Comprehensive Cancer Center of Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
RECRUITINGThe Comprehensive Cancer Center of Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
RECRUITINGNumber of participants with Adverse Events using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in patients
Time frame: 6 months
Response Rate
Time frame: 90 days
Progression free survival (PFS)
Time frame: up to 1 year
Overall Survival (OS)
Time frame: up to 3 years
The duration of the normalization of tumor marker
Time frame: up to 3 years
Interferon-γ change of T cells in the peripheral blood stimulated by tumor antigens
Time frame: Baseline and 1 month, 3 months and 6 months
Th1/Th2 change in the peripheral blood
Time frame: Baseline and 1 month, 3 months and 6 months
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