Autologous Natural Killer T Cells Infusion for the Treatment of Cancer
NCT ID: NCT01801852
Last Updated: 2016-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2013-01-31
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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NKT cells
NKT cells treatment plus regular treatment
NKT cells
Interventions
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NKT cells
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
90 Years
ALL
No
Sponsors
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Tsinghua University
OTHER
Chinese PLA General Hospital
OTHER
Responsible Party
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Han weidong
PI
Locations
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Biotherapeutic Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHN-PLAGH-BT-003
Identifier Type: -
Identifier Source: org_study_id
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