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

NCT03198923 | Unknown Phase 1

• 1 other identifier: NKNKTLC001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• The incidence of adverse events following infusion of NK and NKT cells

  30 days post-infusion

• Overall Survival (OS)

  Approximately 3 years

Secondary Outcomes (3)

• Progression-Free Survival (PFS)

  Approximately 1 years

• Objective Response Rate (ORR)

  up to 24 weeks

• Tumor Marker

  up to 24 weeks

Study Arms (1)

natural killer and natural killer T cell

EXPERIMENTAL

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

Interventions

natural killer and natural killer T cell BIOLOGICAL

The eligible patients are infused with 10 doses of (2-2.5)x10\^9 NK and NKT cells in one course of treatment.

natural killer and natural killer T cell

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wenxiang Wang: lead
• Shanghai Houchao Biotechnology Co., Ltd: collaborator

Study Sites (1)

Hunan Provincal Tumor Hospital

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Wenxiang Wang, PhD

  Hunan Province Tumor Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nong Yang, MD

CONTACT

+86 731 89762323; yangnong0217@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: June 26, 2017
• Study Start: September 13, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2020
• Last Updated: September 25, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)