Suspended
Phase 1 Study of Autologous Natural Killer T Cells Infusion in Treating Patients With Tumors
What is being tested
NKT cells
Biological
Who is being recruted
Urogenital Diseases+33
+ Genital Diseases
+ Breast Diseases
From 18 to 90 Years
+22 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: January 2013
Summary
Principal SponsorChinese PLA General Hospital
Study ContactHan Weidong, DoctorMore contacts
Last updated: January 28, 2016Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2013
Actual date on which the first participant was enrolled.A randomized controlled trial on the efficacy and safety of autologous natural killer T (NKT) cells infusion treatment in advanced cancer.
Principal SponsorChinese PLA General Hospital
Study ContactHan Weidong, DoctorMore contacts
Last updated: January 28, 2016Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
300 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 90 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Urogenital DiseasesGenital DiseasesBreast DiseasesColonic DiseasesDigestive System DiseasesDigestive System NeoplasmsEndocrine System DiseasesEndocrine Gland NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsGenital Diseases, MaleGenital Neoplasms, MaleIntestinal DiseasesIntestinal NeoplasmsLiver DiseasesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissuePancreatic DiseasesProstatic DiseasesSkin DiseasesUrogenital NeoplasmsColorectal NeoplasmsSkin and Connective Tissue DiseasesNeuroectodermal TumorsNeoplasms, NeuroepithelialMale Urogenital DiseasesBreast NeoplasmsColonic NeoplasmsGliomaLiver NeoplasmsPancreatic NeoplasmsProstatic Neoplasms
Criteria
9 inclusion criteria required to participate
Able to comprehend and sign an informed consent document and comply with the requirements of the study
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
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
Life expectancy of >= 24 weeks as measured by the Eastern Cooperative Oncology Group (ECOG) performance status
Show More Criteria
13 exclusion criteria prevent from participating
Age of less than 18 years or over 80 years of age
Culture fails to meet specifications for study
Documented/confirmed positive testing for hepatitis B, hepatitis C, HIV, or CMV
Failure or refusal to sign informed consent for the study
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalNKT cells treatment plus regular treatment
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Recruiting
Biotherapeutic Department of Chinese PLA General Hospital
Beijing, ChinaOpen Biotherapeutic Department of Chinese PLA General Hospital in Google MapsSuspendedOne Study Center