Autologous Natural Killer T Cells Infusion for the Treatment of Cancer

Breast Cancer Clinical Trial

Official title:

Phase 1 Study of Autologous Natural Killer T Cells Infusion in Treating Patients With Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01801852
• Other study ID #: CHN-PLAGH-BT-003
• Status: Recruiting
• Phase: N/A
• First received: February 22, 2013
• Last updated: January 26, 2016
• Start date: January 2013
• Est. completion date: June 2017

Study information

• Verified date: January 2016
• Source: Chinese PLA General Hospital
• Contact: Han Weidong, Doctor
• Phone: +86-10-66937463
• Email: hanwdrsw[@]sina.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee of Chinese PLA General Hospital
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Colon Cancer
• Glioma
• Hepatocellular Cancer
• Liver Neoplasms
• Pancreatic Cancer
• Pancreatic Neoplasms
• Prostate Cancer
• Squamous Cell Lung Cancer

Intervention

Biological:
• NKT cells

Locations

Country	Name	City	State
China	Biotherapeutic Department of Chinese PLA General Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	Tsinghua University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Anti-tumor responses to NKT cells infusions		at least once within 30 days afther completing four-cycle treatment	No