Clinical Efficacy and Safety of NK and NKT Cells Infusion in Patients With Non Small Cell Lung Cancer

A Phase 1/2 Safety and Efficacy Study of Natural Killer and Natural Killer T Cell Immunotherapy in Patients With Non Small Cell Lung Cancer

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.

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