search
Back to results

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

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
natural killer and natural killer T cell
Sponsored by
Wenxiang Wang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hunan Provincal Tumor HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

natural killer and natural killer T cell

Arm Description

The eligible patients are infused with ten doses of (2-2.5)x10^9 NK and NKT cells in one course of treatment.

Outcomes

Primary Outcome Measures

The incidence of adverse events following infusion of NK and NKT cells
Overall Survival (OS)

Secondary Outcome Measures

Progression-Free Survival (PFS)
Objective Response Rate (ORR)
confirmed by CT or MRI, or confirmed by biopsy
Tumor Marker

Full Information

First Posted
June 22, 2017
Last Updated
September 21, 2017
Sponsor
Wenxiang Wang
Collaborators
Shanghai Houchao Biotechnology Co., Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT03198923
Brief Title
Clinical Efficacy and Safety of NK and NKT Cells Infusion in Patients With Non Small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 13, 2017 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wenxiang Wang
Collaborators
Shanghai Houchao Biotechnology Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
natural killer and natural killer T cell
Arm Type
Experimental
Arm Description
The eligible patients are infused with ten doses of (2-2.5)x10^9 NK and NKT cells in one course of treatment.
Intervention Type
Biological
Intervention Name(s)
natural killer and natural killer T cell
Intervention Description
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 Measure Information:
Title
The incidence of adverse events following infusion of NK and NKT cells
Time Frame
30 days post-infusion
Title
Overall Survival (OS)
Time Frame
Approximately 3 years
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Time Frame
Approximately 1 years
Title
Objective Response Rate (ORR)
Description
confirmed by CT or MRI, or confirmed by biopsy
Time Frame
up to 24 weeks
Title
Tumor Marker
Time Frame
up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nong Yang, MD
Phone
+86 731 89762323
Email
yangnong0217@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenxiang Wang, PhD
Organizational Affiliation
Hunan Province Tumor Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunan Provincal Tumor Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenxiang Wang, PhD
Phone
+867319762110
Email
wwx78@foxmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs