clinical efficacy and safety of nk and nkt cells infusion in patients with non small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: 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.

Eligibility criteria:
inclusion criteria: * age: 18 to 75 years, male or female * histological or cytologically diagnosis of non-small cell lung cancer * recurrent or metastatic after surgical treatment * the pathology must be an assessable disease, signal lesion not exceeding 3 cm in diameter (measurable by ct scan or mri)，number of lymph node metastasis is less than 5 * refractory to standard treatments (e.g., chemotherapy, radiation, etc.) * no chemotherapy and radiation therapy to be planned recently * patients must have a karnofsky performance status greater than or equal to 70% * life expectancy greater than 3 months * able and willing to give witnessed, written informed consent form prior to receiving any study related procedure * agree that progress of the disease must be radiographically measurable by computerized tomography (ct) scanning technique or magnetic resonance imaging (mri) (per recist1.1 criteria) * agrees to participate in long-term follow-up for up to 3 years, if received nk and nkt infusion * laboratory values within the following ranges prior to receiving treatment of study agent: peripheral blood cells \>3×10\^9 /l; number of lymphocytes \>1.0×10\^9 /l; lymphocyte ratio \>18%; inr\<1.5. exclusion criteria: * patients with no surgical treatment * patients within concurrent chemotherapy or radiation * known or suspected allergy to the investigational agent or any agent given in association with this trial * negative hiv antigen and antibody, hepatitis b surface antigen and hepatitis c pcr within 21 days prior to enrollment * history of immunodeficiency disease or autoimmune disease * patients with chronic disease which is undergoing immune reagents or hormone therapy * serious infections requiring antibiotics, bleeding disorders * previous bone marrow or stem cell transplant, or organ allograft * concurrent other medical condition that would prevent the patient from undergoing protocol-based therapy * participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent * pregnant or breast-feeding patients * lack of availability of a patient for immunological and clinical follow-up

Keywords: non-small cell lung cancer