This study is to evaluate the safety and efficacy of a therapeutic vaccine in combination with PD-1 knockout T cells in the treatment of advanced prostate cancer.
This is a phase 1/2 clinical study investigating the safety and efficacy of a therapeutic vaccine in combination with PD-1 knockout T cells in the treatment of advanced prostate cancer. The therapeutic vaccine is a customized product involving ex vivo treatment of the patient's peripheral blood mononuclear cells with a recombinant fusion protein (PAP-GM-CSF) to activate the expression of the antigen that would activate the immune function to kill cancer cells. The PD-1 knockout engineered T cells are also prepared using patient's T cells in which PD-1 gene will be knocked out using CRISPR Cas9 technology. The therapeutic vaccine and PD-1 knockout T cells will be infused back to the patient in 3 times with a 2-week interval.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
The therapeutic vaccine will be custom prepared ex vivo using the peripheral mononuclear cells from the patient and the vaccine which presented as maturated dendritic cells will be infused back to the patients in 3 times.
PD-1 knockout T cells will be custom prepared ex vivo using the white blood cells from the patient and the maturated PD-1 knockout T cells will be infused back to the patients in 3 times.
First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China
RECRUITINGProfessor Size Chen
Guangzhou, Guangdong, China
RECRUITINGNumber of participants with adverse events and dose limiting toxicities as assessed by CTCAE v4.0
Safety and tolerability of dose of therapeutic vaccine in combination with PD-1 Knockout T cells will be assessed using CTCAE v4.0
Time frame: 6 months
Response Rate
Will be assessed according to the revised RECIST guideline v1.1
Time frame: 6 months
Progression free survival - PFS
Time from treatment to date of first documented progression or date of death
Time frame: Up to 12 months
Overall Survival - OS
Measure the time from the commencement of treatment to death
Time frame: Death
Peripheral blood circulating tumor DNA
Circuiting tumor DNA will be measured at baseline and 6 weeks after treatment
Time frame: 8 weeks
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