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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Biological: natural killer and natural killer T cell


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: natural killer and natural killer T cell<br>The eligible patients are infused with ten doses of (2-2.5)x10^9 NK and NKT cells in one course of treatment. | Biological: natural killer and natural killer T cell<br>* The eligible patients are infused with 10 doses of (2-2.5)x10^9 NK and NKT cells in one course of treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse events following infusion of NK and NKT cells |  | 30 days post-infusion | 
| Overall Survival (OS) |  | Approximately 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) |  | Approximately 1 years | 
| Objective Response Rate (ORR) | confirmed by CT or MRI, or confirmed by biopsy | up to 24 weeks | 
| Tumor Marker |  | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-small Cell Lung Cancer