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

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ClinicalTrials.gov Identifier: NCT03198923
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
Shanghai Houchao Biotechnology Co., Ltd
Information provided by (Responsible Party):
Wenxiang Wang, Hunan Province Tumor Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Biological: natural killer and natural killer T cell Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 13, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: natural killer and natural killer T cell
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
The eligible patients are infused with 10 doses of (2-2.5)x10^9 NK and NKT cells in one course of treatment.




Primary Outcome Measures :
  1. The incidence of adverse events following infusion of NK and NKT cells [ Time Frame: 30 days post-infusion ]
  2. Overall Survival (OS) [ Time Frame: Approximately 3 years ]

Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: Approximately 1 years ]
  2. Objective Response Rate (ORR) [ Time Frame: up to 24 weeks ]
    confirmed by CT or MRI, or confirmed by biopsy

  3. Tumor Marker [ Time Frame: up to 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198923


Contacts
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Contact: Nong Yang, MD +86 731 89762323 yangnong0217@163.com

Locations
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China, Hunan
Hunan Provincal Tumor Hospital Recruiting
Changsha, Hunan, China, 410013
Contact: Wenxiang Wang, PhD    +867319762110    wwx78@foxmail.com   
Sponsors and Collaborators
Wenxiang Wang
Shanghai Houchao Biotechnology Co., Ltd
Investigators
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Principal Investigator: Wenxiang Wang, PhD Hunan Province Tumor Hospital

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Responsible Party: Wenxiang Wang, Professor, Hunan Province Tumor Hospital
ClinicalTrials.gov Identifier: NCT03198923     History of Changes
Other Study ID Numbers: NKNKTLC001
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wenxiang Wang, Hunan Province Tumor Hospital:
Non-small Cell Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms