Autologous Natural Killer T Cells Infusion for the Treatment of Cancer
Phase 1 Study of Autologous Natural Killer T Cells Infusion in Treating Patients With Tumors
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Jan 2013
Typical duration for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 22, 2013
CompletedFirst Posted
Study publicly available on registry
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJanuary 28, 2016
January 1, 2016
3.3 years
February 22, 2013
January 26, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Anti-tumor responses to NKT cells infusions
at least once within 30 days afther completing four-cycle treatment
Study Arms (1)
NKT cells
EXPERIMENTALNKT cells treatment plus regular treatment
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chinese PLA General Hospitallead
- Tsinghua Universitycollaborator
Study Sites (1)
Biotherapeutic Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
February 22, 2013
First Posted
March 1, 2013
Study Start
January 1, 2013
Primary Completion
May 1, 2016
Study Completion
June 1, 2017
Last Updated
January 28, 2016
Record last verified: 2016-01