The purpose of this study is to assess the safety and effectiveness of natural killer (NK) cell and natural killer T (NKT) cell-based immunotherapy in subjects with non small cell lung cancer.
With the development of oncology and immunology in recent years, immunotherapy represents a novel path to obtain a durable and long-lasting response in cancer patients. NK and NKT cells are expanded conventionally from peripheral blood mononuclear cells by addition of a variety of cytokines in vitro culture. Our previous studies demonstrated that the expansion of NK and NKT cells in a clinical usage scale from peripheral blood mononuclear cells is feasible. Those expanded NK and NKT cells exhibit antitumor effect in vitro and in vivo against a variety of tumor cells. The current study proposes a 3-course treatment of doses administered at one week intervals with monitoring at each administration plus 4 weeks after the last dose. The total study time (apheresis through last follow-up) is estimated at 3 year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The eligible patients are infused with 10 doses of (2-2.5)x10\^9 NK and NKT cells in one course of treatment.
Hunan Provincal Tumor Hospital
Changsha, Hunan, China
RECRUITINGThe incidence of adverse events following infusion of NK and NKT cells
Time frame: 30 days post-infusion
Overall Survival (OS)
Time frame: Approximately 3 years
Progression-Free Survival (PFS)
Time frame: Approximately 1 years
Objective Response Rate (ORR)
confirmed by CT or MRI, or confirmed by biopsy
Time frame: up to 24 weeks
Tumor Marker
Time frame: up to 24 weeks
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