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Trial record 7 of 34 for:    Han weidong

Autologous Natural Killer T Cells Infusion for the Treatment of Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01801852
Recruitment Status : Unknown
Verified January 2016 by Han weidong, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : March 1, 2013
Last Update Posted : January 28, 2016
Tsinghua University
Information provided by (Responsible Party):
Han weidong, Chinese PLA General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Glioma Hepatocellular Cancer Squamous Cell Lung Cancer Pancreatic Cancer Colon Cancer Prostate Cancer Biological: NKT cells Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Autologous Natural Killer T Cells Infusion in Treating Patients With Tumors
Study Start Date : January 2013
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: NKT cells
NKT cells treatment plus regular treatment
Biological: NKT cells

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

Secondary Outcome Measures :
  1. Anti-tumor responses to NKT cells infusions [ Time Frame: at least once within 30 days afther completing four-cycle treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:•Male or female not less than 18 years of age or over 80 years of age.

  • 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.

Exclusion Criteria:•No measurable malignant disease by CT scan or tumor markers.

  • 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.

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 identifier (NCT number): NCT01801852

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Contact: Han Weidong, Doctor +86-10-66937463
Contact: Zhang Minghui, Doctor +86-10-13240905431

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China, Beijing
Biotherapeutic Department of Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Feng Kaichao, Doctor    +86-10-13811421950   
Contact: Zhang Minghui, Doctor    86-10-13240905431   
Sponsors and Collaborators
Chinese PLA General Hospital
Tsinghua University

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Responsible Party: Han weidong, PI, Chinese PLA General Hospital Identifier: NCT01801852     History of Changes
Other Study ID Numbers: CHN-PLAGH-BT-003
First Posted: March 1, 2013    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Liver Neoplasms
Carcinoma, Hepatocellular
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type