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.

Study Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Biological: natural killer and natural killer T cell

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • Recruiting
      • Hunan Provincal Tumor Hospital
      • Contact: Wenxiang Wang, PhD; Phone Number: +867319762110; Email: wwx78@foxmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Wenxiang Wang
• Collaborators: Shanghai Houchao Biotechnology Co., Ltd
• Investigators: Principal Investigator: Wenxiang Wang, PhD, Hunan Province Tumor Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: June 22, 2017
• First Submitted That Met QC Criteria: June 22, 2017
• First Posted (Actual): June 26, 2017

Study Record Updates

• Last Update Posted (Actual): September 25, 2017
• Last Update Submitted That Met QC Criteria: September 21, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Non-small Cell Lung Cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: NKNKTLC001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No