This study will evaluate the safety of PD-1 knockout engineered T cells in treating castration resistant prostate cancer (CRPC). Blood samples will also be collected for research purposes.
This is a dose-escalation study of ex-vivo knocked-out, expanded, and selected PD-1 knockout-T cells from autologous origin. Patients are assigned to 1 of 3 treatment groups to determine the maximal tolerant dose. After the lower number of cycles are considered tolerant, an arm of the next higher number of cycles will be open to next patients. Biomarkers and immunological markers are collected and analyzed as well.
Study Type
OBSERVATIONAL
PD-1 Knockout T Cells and PD-1 wild-type T Cells will be made by Cell Biotech Co., Ltd. 2x107/kg T cells will be used for test group and comparable group separately.
Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion. Interleukin-2 (IL-2) will be given in the following 5 days, 720000 international unit(IU)/Kg/day (if tolerant).
Interleukin-2 (IL-2) will be given in the following 5 days after cell infusion, 720000 international unit(IU)/Kg/ day (if tolerant).
Department of Urology Peking University First Hospital
Beijing, Beijing Municipality, China
Number of participants with Adverse Events and/or Dose Limiting Toxicities as a Measure of Safety and tolerability of dose of PD-1 Knockout T cells using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in patients
Time frame: Dose Escalation - Approximately 6 months
Response Rate:Response will be evaluated according to RECIST v1.1
Time frame: 90 days
Progression free survival - PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to average 10 months
Overall Survival - OS
Time frame: The time from randomization to death from any cause, assessed up to 2 years
Peripheral blood circulating tumor DNA
Time frame: 6 weeks
Temporal Interleukin-2 change in the peripheral blood
Time frame: Baseline and 1 month and 3 months
Temporal Interferon-γ change in the peripheral blood
Time frame: Baseline and 1 month and 3 months
Temporal Interleukin-6 change in the peripheral blood
Time frame: Baseline and 1 month and 3 months
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