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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

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