Protocol summary
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Study aim
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Investigation of the safety of autologous immune cells injection enriched with NK (Natural killer) cells to the patients with refractory breast cancer
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Design
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In the present study, one group including three refractory breast cancer patients with inclusion criteria enrolled.
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Settings and conduct
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In this study, after peripheral blood mononuclear cells isolation, the cells will be co-cultured, activate and proliferate with the specific antibodies and the culture medium for two weeks in the clean room, then the cells will be injected to the patients. This process will be performed every 2 weeks during 3 months (6 injections)
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Participants/Inclusion and exclusion criteria
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Female patients with refractory breast cancer, Infiltrative Ductal Carcinoma (IDC) type, without any infection, autoimmune disease, and pregnancy will participate in the study.
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Intervention groups
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One group of patients including 3 patients with refractory breast cancer will participate in this study. Autologous immune cells enriched with Natural killer cells will be injected to the patients every two weeks during three months (six injections).
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Main outcome variables
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Investigation of the safety of the autologous immune cells enriched with Natural killer cells injection to the patients with refractory breast cancer is the main outcome variable of the present study.
General information
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Reason for update
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Acronym
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ICR-NKCT-17
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IRCT registration information
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IRCT registration number:
IRCT20160419027479N2
Registration date:
2018-02-14, 1396/11/25
Registration timing:
prospective
Last update:
2018-03-01, 1396/12/10
Update count:
1
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Registration date
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2018-02-14, 1396/11/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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VC for research and technology and Institute for Stem Cells and Regenerative Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
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Expected recruitment start date
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2018-04-21, 1397/02/01
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Expected recruitment end date
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2019-03-21, 1398/01/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigation of the safety of autologous immune cells injection enriched with NK (Natural killer) cells to the patients with refractory breast cancer
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Public title
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Investigation of treatment of patients with refractory breast cancer using autologous immune cells enriched with NK cells
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with breast cancer, Infiltrative Ductal Carcinoma (IDC)
Patients with end stage breast cancer (Stage 4)
Patients with refractory breast cancer based on National Comprehensive Cancer Network (NCCN) and European Society for Medical Oncology (ESMO) guidelines
Triple negative (ER-,PR- and Her2-) breast cancer patients
Patients with the minimum age of 18 years old and maximum 60 years old
Performance status =0 or 1
Life expectancy for patients: more than 3 months
Exclusion criteria:
Patients with autoimmune disease
Patients with active infection
Patients who spend the intensive radiotherapy
Pregnant patients
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Age
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From 18 years old to 60 years old
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Gender
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Female
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Phase
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1
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Groups that have been masked
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No information
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Sample size
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Target sample size:
3
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-09-17, 1396/06/26
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Ethics committee reference number
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IR.SUMS.REC.1396.104
Health conditions studied
1
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Description of health condition studied
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Refractory breast cancer
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Determining how well NK enriched immune cells can be tolerated in patients. Safety and toxicity will be determined based on Common Terminology Criteria for Adverse Events (CTCAEs) guideline
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Timepoint
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The period between the first injection and 2 months after the last injection
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Method of measurement
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According to the CTCAEs [Common Terminology Criteria for Adverse Events]
Secondary outcomes
1
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Description
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Immunological responses in the patients
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Timepoint
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The period between the first injection and 2 months after the last injection
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Method of measurement
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The flowcytometeric analysis of different immune cells percentage including B, T (CD4+ and CD8+), NK subsets, CD4+ regulatory T cells in PBMCs isolated from the patients
Intervention groups
1
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Description
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Autologous NK enriched immune cells injection into the patients every 2 weeks during 3 months
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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VC for Research and Technology and Institute for stem cells and regenerative medicine, Shiraz Unive
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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1) Clinical and pathological characteristics of the [patients, including tumor type, tumor grade, tumor stage, LN involvement and metastasis at the time of diagnosis
2) Clinical response to the treatment regimen, as well as the pathological and immunological findings before and after cell therapy
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When the data will become available and for how long
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Six months following the publication of the results
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To whom data/document is available
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Researchers, scientist and physicians
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Under which criteria data/document could be used
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Using the data for research with the permission of the principal investigators
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From where data/document is obtainable
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Dr. Nasrollah Erfani/ Mrs. Somayeh Rezaeifard
Shiraz Institute for Cancer Research and Department of Immunology,
School of Medicine
ُُShiraz University of Medical Sciences
Zand Av.
Shiraz. Iran
Tel: +98 (71) 32303687
ermail: erfanin@sums.ac.ir/ srezaeifard@sums.ac.ir
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What processes are involved for a request to access data/document
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1) Putting the application
2) Processing the application by the investigators
3) Providing the data in two weeks
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Comments
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