An Early Phase 1 interventional study of Zeushield Cytotoxic T Lymphocytes in Non-small Cell Lung Cancer, sponsored by Yu Fenglei. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-23.
Sponsored by Yu Fenglei · Early Phase 1, Interventional, and Treatment
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).
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 10 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →This is the only study on the registry with Yu Fenglei as lead sponsor.
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Exclusion Criteria:
Enrolled patients will receive Zeushield Cytotoxic T Lymphocytes by infusion
Biological: Zeushield Cytotoxic T Lymphocytes
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.
Number 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
Plan to share: Undecided
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