Combinational Cell Therapy using NK cells and Erbitux in Patients with Advanced Gastric Adenocarcinoma
Design
A pilot single arm clinical trial of 6 patients
Settings and conduct
1- Patient selection. 2- Isolation of mononuclear cells isolated using ficoll and density gradient centrifugation and then using an NK cells isolation kit, NK cells will be separated 3- Pretreatment of NK cells with Anti-NKG2A 4- Injection protocol including conditioning regime, erbitux injection, and intravenously injection of 7x10^8 cells
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Age between 20 and 60 years
- Histologically confirmed adenocarcinoma of the stomach
- Patients who have relapsed at least once after gastrectomy and did not respond to chemotherapy.
- Patients receiving the same chemotherapy regimen.
- Patients with the same tumor size.
- Diffuse form of histopathology.
- Eastern Cooperative Oncology Group (ECOG) performance status<2
- Life expectancy of at least 3 months
- Absence of heart problems
- Proper functioning of vital organs
Exclusion criteria:
- Positive test for HIV, HTLV-1, syphilis, hepatitis B and C infections
- Severe active infection
- Serious complications such as diabetes mellitus, unstable angina, or myocardial infarction within 3 months
- Pregnancy or lactation period
- History of autoimmune diseases and hypersensitivity
- History of receiving any type of cell therapy in the last 6 months
Intervention groups
Intravenous injection of Erbitux and the number of 7x10^5 NK cells in 3 periods with an interval of 5 days to 3 patients with GAC
Control group: Erbitux with a dose of 400 mg/m2 one day before the start of cell therapy and repeat for every 2 weeks up to 3 doses of injection
Main outcome variables
Follow- up of patients after each injection and 28 days after the last injection based on clinical response and safety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140818018842N36
Registration date:2023-12-09, 1402/09/18
Registration timing:prospective
Last update:2023-12-09, 1402/09/18
Update count:0
Registration date
2023-12-09, 1402/09/18
Registrant information
Name
Leyla Sharifi Aliabadi
Name of organization / entity
Research Institute for Hematology, Oncology and Stem Cell Transplantation,Tehran University of Medic
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 3691
Email address
ctu@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Combinational Cell Therapy using Natural Killer Cells and Erbitux in Patients with Advanced Gastric Adenocarcinoma
Public title
Combinational Cell Therapy using Natural Killer Cells and Erbitux in Patients with Advanced Gastric Adenocarcinoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 and 60 years- Histologically confirmed adenocarcinoma of the stomach- Patients who have relapsed at least once after gastrectomy and did not respond to chemotherapy.- Patients receiving the same chemotherapy regimen.- Patients with the same tumor size.- Diffuse form of histopathology.- Eastern Cooperative Oncology Group (ECOG) performance status<2- Life expectancy of at least 3 months- Absence of heart problems- Proper functioning of vital organs:leukocyte count ≥3000/mm3neutrophil count ≥1500/mm3platelet count ≥100,000/mm3hemoglobin ≥9.0 g/dLserum aspartate aminotransferase (AST) ≤100 IU/Lalanine aminotransferase (ALT) ≤100 IU/Lserum total bilirubin ≤2 mg/dLserum creatinine ≤1.5 mg/dLblood urea ≤25 mg/dL
Exclusion criteria:
- Positive test for HIV, HTLV-1, syphilis, hepatitis B and C infections- Severe active infection- Serious complications such as diabetes mellitus, unstable angina, or myocardial infarction within 3 months- Pregnancy or lactation period- History of autoimmune diseases and hypersensitivity- History of receiving any type of cell therapy in the last 6 months
Age
From 20 years old to 60 months old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
3
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of The Institute of Pharmaceutical Sciences -Tehran University of Medical
Street address
3rd Floor, No 10, Endocrinology and Metabolism Research Institute, Jalal-Al-Ahmad St., Chamran Hwy., Tehran-Iran
City
Tehran
Province
Tehran
Postal code
1411713119
Approval date
2023-09-20, 1402/06/29
Ethics committee reference number
IR.TUMS.TIPS.REC.1402.080
Health conditions studied
1
Description of health condition studied
Gastric Adenocarcinoma
ICD-10 code
C16. 9
ICD-10 code description
C16. 9 Malignant neoplasm: Stomach, unspecified
Primary outcomes
1
Description
Checking the safety and toxicity of the injected cells
Timepoint
28 days
Method of measurement
Any side effects related to cell injection will be checked and recorded during the injection and up to 28 days after the injection.If a complication is seen during or after the infusion, the following actions will be taken based on the CTCAE guideline:In grade 1, only the infusion is stopped.In grades 2 and 3, the infusion is stopped along with anti-allergic treatments, including corticosteroids and antihistamines.In grade 4, in addition to the above, resuscitation measures and care in the ICU department are also recommended.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intravenous injection of Erbitux according to the standard protocol and the number of 7x10^5 NK cells in 3 periods with an interval of 5 days to 3 patients with advanced cancer GAC
Category
Treatment - Other
2
Description
Control group: ٍErbitux is injected intravenously with a dose of 400 mg/m^2one day before the start of the first cycle of cell injection. Then every 2 weeks up to 3 doses of injection will be repeated.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Dr Maryam Barkhordar
Street address
Kargar Shomali Ave, Shariati Hospital, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8822 4140
Email
barkhordarm.n@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Maryam Barkhordar
Street address
Kargar Shomali Ave, Shariati Hospital, Tehran
City
Tehran
Province
Tehran
Postal code
00982184902635
Phone
+98 913 185 6733
Email
barkhordarm.n@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
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
Dr Javad Verdi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 87, Third floor, Building No.2, School of Advanced Technologies in Medicine, Italia st, Keshavarz blv. Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417755469
Phone
+98 21 4305 2000
Email
javadverdi2019@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohamad Ahmadvand
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Kargar Shomali Ave, Shariati Hospital, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8822 4140
Email
ahmadvand.mohamad64@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Samareh Salavati
Position
PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
No. 87, Third floor, Building No.2, School of Advanced Technologies in Medicine, Italia st, Keshavarz blv. Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417755469
Phone
+98 21 4305 2000
Email
m.samareh72@gmail.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