Autologous Natural Killer T Cells Infusion For The Treatment Of Cancer

Study Overview

Autologous Natural Killer T Cells Infusion for the Treatment of Cancer

The purpose of this study is to assess the safety and effectiveness of natural killer T (NKT) cell-based autologous adoptive immunotherapy in subjects with metastatic, treatment-refractory breast cancer, glioma, hepatocellular carcinoma, squamous cell lung cancer, pancreatic cancer, colon cancer or prostate cancer.

A randomized controlled trial on the efficacy and safety of autologous natural killer T (NKT) cells infusion treatment in advanced cancer.

Breast Cancer
Glioma
Hepatocellular Cancer
Squamous Cell Lung Cancer
Pancreatic Cancer
Colon Cancer
Prostate Cancer

BIOLOGICAL: NKT cells

CHN-PLAGH-BT-003

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-02-22	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-01-26
First Submitted that Met QC Criteria 2013-02-28	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-01-28
First Posted (ESTIMATED) 2013-03-01	Results First Posted N/A	Last Verified 2016-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: NKT cells NKT cells treatment plus regular treatment	BIOLOGICAL: NKT cells

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: NKT cells

NKT cells treatment plus regular treatment

BIOLOGICAL: NKT cells

Primary Outcome Measures	Measure Description	Time Frame
Occurrence of study related adverse events	defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment	Until week 24

Secondary Outcome Measures	Measure Description	Time Frame
Anti-tumor responses to NKT cells infusions		at least once within 30 days afther completing four-cycle treatment

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Han Weidong, Doctor

Phone Number: +86-10-66937463

Email: hanwdrsw@sina.com

Study Contact Backup

Name: Zhang Minghui, Doctor

Phone Number: +86-10-13240905431

Email: immunolzhang@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Life expectancy of ≥ 24 weeks as measured by the Eastern Cooperative Oncology Group (ECOG) performance status.
Subjects must present with one of the following disease pathologies: Breast Cancer, Glioma, Hepatocellular Cancer, Squamous Cell Lung Cancer, Pancreatic Cancer, Colon Cancer or Prostate Cancer
The pathology must be an assessable disease (measurable by CT scan or MRI) that is refractory to standard treatments (e.g., chemotherapy, radiation, etc.)
Negative for hepatitis B, hepatitis C, HIV, and CMV.
Subjects must present with leukocyte counts above 3,000/μL and platelet counts above 100,000/ μL.
Subjects must present with minimum hemoglobin levels of 10.
If female, subject is surgically sterile (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), post menopausal (no menses >12 months), or using a high-efficiency method of contraception such as implant, injectable, combination oral contraceptive, intrauterine device (IUD) or sexual abstinence, or has a vasectomized partner.
If female of childbearing potential, subject is not pregnant, breast-feeding or planning a pregnancy during the study, and has a negative pregnancy test on screening visit.
Able to comprehend and sign an informed consent document and comply with the requirements of the study.

Life expectancy of ≤ 24 weeks as measured by the Eastern Cooperative Oncology Group (ECOG) performance status.
Age of less than 18 years or over 80 years of age.
Documented/confirmed positive testing for hepatitis B, hepatitis C, HIV, or CMV.
Prior or current history of autoimmune disease.
Pregnant or lactating women.
Leukocyte count < 3,000 /μL prior to leukapheresis.
Platelet count < 100,000/μL prior to leukapheresis.
Hemoglobin levels below 10.
PTT (prothrombin time) of < 12 seconds or > than 15 seconds.
aPTT (activated partial thromboplastin time) of < 25 seconds or > than 39 seconds.
Failure or refusal to sign informed consent for the study.
Culture fails to meet specifications for study.
Subject has any other medical condition that, in the opinion of the investigator, might significantly affect the ability to safely participate in the study or affect the conduct of the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Tsinghua University

Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record