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Trial Title:
Autologous Natural Killer T Cells Infusion for the Treatment of Cancer
NCT ID:
NCT01801852
Condition:
Breast Cancer
Glioma
Hepatocellular Cancer
Squamous Cell Lung Cancer
Pancreatic Cancer
Colon Cancer
Prostate Cancer
Conditions: Official terms:
Liver Neoplasms
Carcinoma, Hepatocellular
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
NKT cells
Arm group label:
NKT cells
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.
Detailed description:
A randomized controlled trial on the efficacy and safety of autologous natural killer T
(NKT) cells infusion treatment in advanced cancer.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Biotherapeutic Department of Chinese PLA General Hospital
Address:
City:
Beijing
Zip:
100853
Country:
China
Status:
Recruiting
Contact:
Last name:
Feng Kaichao, Doctor
Phone:
+86-10-13811421950
Email:
timothyfkc@yahoo.com.cn
Contact backup:
Last name:
Zhang Minghui, Doctor
Phone:
86-10-13240905431
Email:
immunolzhang@gmail.com
Start date:
January 2013
Completion date:
June 2017
Lead sponsor:
Agency:
Chinese PLA General Hospital
Agency class:
Other
Collaborator:
Agency:
Tsinghua University
Agency class:
Other
Source:
Chinese PLA General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01801852