The main goal of this phase I clinical trial is to evaluate the safety and efficacy of personalized induced pluripotent stem cell-derived natural killer cell therapy on patients with advanced breast cancer.
Design
The present study is a single-group non-randomized phase I clinical trial with non-blinded post- and pre-intervention outcome assessment.
Settings and conduct
Following obtaining informed consent, a simple skin biopsy from the candidate's mastoid area will be taken for iPSCs manipulation and then NK cells generation. Finally, patients receive a determined dosage of the generated NK cells through three infusions. All of the evaluations will be conducted at the Cancer Institute of Imam Khomeini Hospital, Tehran, Iran.
Participants/Inclusion and exclusion criteria
The ideal candidates for this study are those with: women between 20 to 70 years of age with the diagnosis of advanced breast cancer by any combination of ER, PR, and HER-2, who are a metastasis lesions and progressed on chemotherapy and/or radiotherapy.
Intervention groups
In this single-group study, 32 patients will be non-randomly recruited. Besides their routine medications, the candidates receive a determined dosage of the generated NK cells (8-10 billion cell/m2) through three infusions courses.
Main outcome variables
Determination of probable toxicity, response to treatment, progression-free survival (PFS), and immune system function following the intervention.
General information
Reason for update
Acronym
iTC Study
IRCT registration information
IRCT registration number:IRCT20200429047241N1
Registration date:2020-08-10, 1399/05/20
Registration timing:prospective
Last update:2020-08-10, 1399/05/20
Update count:0
Registration date
2020-08-10, 1399/05/20
Registrant information
Name
Habibollah Mahmoodzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2509
Email address
hmahmoodzadeh@tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2021-02-18, 1399/11/30
Expected recruitment end date
2025-02-18, 1403/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Personalized Immunology of Patients with Advanced Breast Cancer Using induced Pluripotent Stem Cell-Derived Natural Killer cells
Public title
A Clinical Trial to Evaluate the Effects of Autologous induced Pluripotent Stem Cell-Derived Natural Killer Cells in Personalized Treatment of Patients with Advanced Metastatic Breast Cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with the diagnosis of ABC by any combination of ER, PR, and HER-2, who are progressed on chemotherapy and/or radiotherapy regimens for their metastatic disease.
Single metastasis patients with a measurable metastasis in the lymph node, lung, liver, and bone.
Women must be between 20 and 70 years of age.
Exclusion criteria:
Patients with active and uncontrolled infections.
Abnormal kidney, lung and liver function, measured by serum creatinine (serum creatinine> 2 mg / dl), saturated oxygen O2 ≤ 96%) (Sat and liver enzymes (ALT / AST> 2.5 x N).
Patients with the other types of cancers unrelated to the primary breast tumors
Age
From 20 years old to 70 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice- Chancellor in Research Affairs-Tehran University of Medical Science
Street address
Cancer Institute, Imam Khomeini Hospital Complex, Doctor Qarib, Keshavarz Boulevard, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2019-06-08, 1398/03/18
Ethics committee reference number
IR.TUMS.VCR.REC.1398.232
Health conditions studied
1
Description of health condition studied
Advanced Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Probable toxicity resulting from Intervention
Timepoint
Pre- and post-intervention
Method of measurement
Physical examination, biochemical and serological tests, and electrocardiography
2
Description
Response to treatment
Timepoint
Pre- and post-intervention
Method of measurement
CT scan, histopathologic observations, and plasma level of tumor markers
3
Description
progression-free survival
Timepoint
post-intervention
Method of measurement
Follow-up
4
Description
Immune system function
Timepoint
Pre- and post-intervention
Method of measurement
Flow cytometry and ELIZA cytokine assay
Secondary outcomes
empty
Intervention groups
1
Description
Candidates besides their standard treatments receive a determined dosage of the generated NK cells (8-10 billion cell/m2) through three intravenous infusions courses.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer Instituted of Iran, Imam Khomeini complex medical center, Tehran, Iran.
Full name of responsible person
Dr. Habibollah Mahmoodzadeh
Street address
Cancer Instituted, Imam Khomeini complex medical center, Keshavarz Boulevard, Doctor Qharib Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1587
Email
hmahmoodzadeh@tums.ac.ir
Web page address
http://www.ikhc.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
International Center for Personalized Medicine (ICPM)
Full name of responsible person
Dr. Karim Nayernia
Street address
Luise–Rainer
City
Düsseldorf
Postal code
40235
Phone
+49 211 436912110
Email
nayernia@p7medicine.com
Web page address
http://www.icpm.center/
Grant name
Grant code / Reference number
ICPM-2019-001
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
International Center for Personalized Medicine (ICPM)
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Foreign
Category of foreign source of funding
UN agencies and international organizations
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamid Khodayari
Position
Researcher
Latest degree
Bachelor
Other areas of specialty/work
Cancer Research
Street address
Cancer Institute of Iran, Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6658 1587
Email
h.khodayari@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Habibolah Mahmoodzadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Surgical Oncology
Street address
Cancer Institute, Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6658 1587
Email
hmahmoodzadeh@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamid Khodayari
Position
Researcher
Latest degree
Bachelor
Other areas of specialty/work
Cancer Research
Street address
Cancer Institute of Iran, Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6658 1587
Email
h.khodayari@hotmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available