A single-center, open-label pilot study to determine the safety, tolerance and engraftment potential of zeushield cytotoxic T lymphocytes in subjects with PD-L1+ positive non-small cell lung cancer.
The purpose of this first in human study is to determine the safety and feasibility of Zeushield Cytotoxic T Lymphocytes(Z-CTLs) in patients with relapsed or refractory NSCLC. Z-CTLs therapy is a novel immunotherapy under investigation in which patients have their T-cells (a type of white blood cell) collected and modified in the laboratory, before they are given back to the patient. The T-cells are modified to transform the intracellular signal domain of PD-1 and CTLA-4 to immune activation stimulus signal and transform T cells to a new kind of cancer-killer cells: zeushield cytotoxic T lymphocytes (Z-CTls).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Three dose levels will be evaluated. Dose Level One: 1.0×10\^5 cells/kg, Dose Level Two: 1.0×10\^6 cells/kg, Dose Level Three: 1.0×10\^7 cells/kg. At the discretion of the investigator, if patients with active disease have stable disease or a response at week 8 or on subsequent evaluations, they are eligible to receive up to 6 additional infusions at 8 to 12 week intervals.
Second Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGNumber of participants with treatment-related adverse events as assessed by CTCAE v4.0
Observe and determine the potential adverse events related to the escalating dose infusion of Z-CTLs such as high fever,jaundice, kidney failure and so on.
Time frame: 8 weeks
Number of Z-CTLs in peripheral blood samples after infusion
Detect Z-CTLs in peripheral blood samples after infusion by flow cytometry every week
Time frame: 8 weeks
Objective response rate (ORR)
the ratio of patients diagnosed as partial remission (PR) to complete remission (CR) according to RECIST 1.1 criteria
Time frame: 2 years
Progression free survival (PFS)
the duration from baseline to PD (audited and confirmed by independent imaging), or to the day of any death event
Time frame: 2 years
Time to tumor progression (TTP)
the duration from baseline to disease starts to get worse or spreads to other parts of the body
Time frame: 2 years
Overall survival (OS)
the time period from the 1st day of treatment to the day of death for any reason. For patients who are still alive at the data analysis day, OS data is subject to the last confirmed time of survival patients
Time frame: 2 years
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