Evaluation of the safety of intrathecal injection of activated allogenic Natural Killer (NK) cells in pediatrics with brain gliomas; A phase I clinical trial
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Recruitment centers
#1
Name of recruitment center - English: Royan ATMP center
Name of recruitment center - Persian: مرکز ATMP رویان
Full name of responsible person - English: Hamid Mahdizadeh
Full name of responsible person - Persian: حمید مهدی زاده
Street address - English: Oncology clinic, ground floor, Royan ATMP center, Golbarg alley, Royan Alley, Hafez street, Banihashem square, Banihashem street, Resalat highway, Tehran, Iran
Street address - Persian: تهران، بزرگراه رسالت، خیابان بنی هاشم، میدان بنی هاشم، خیابان حافظ، کوچه رویان، کوچه گلبرگ، ساختمان ATMP رویان، طبقه همکف، کلینیک انکولوژی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1665659911
Phone: +98 21 2356 2000
Fax:
Email: mahdizadehmd@yahoo.com
Web page address:
Name of recruitment center - English: Royan ATMP center Name of recruitment center - Persian: مرکز ATMP رویان Full name of responsible person - English: Hamid Mahdizadeh Full name of responsible person - Persian: حمید مهدی زاده Street address - English: Oncology clinic, ground floor, Royan ATMP center, Golbarg alley, Royan Alley, Hafez street, Banihashem square, Banihashem street, Resalat highway, Tehran, Iran Street address - Persian: تهران، بزرگراه رسالت، خیابان بنی هاشم، میدان بنی هاشم، خیابان حافظ، کوچه رویان، کوچه گلبرگ، ساختمان ATMP رویان، طبقه همکف، کلینیک انکولوژی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1665659911 Phone: +98 21 2356 2000 Fax: Email: mahdizadehmd@yahoo.com Web page address:
Sponsors / Funding sources
#1
100
10
10010
#2
contact.organization_id:
Name of organization / entity - English: Kian Immune Cell company
Name of organization / entity - Persian: شرکت کیان ایمن سلول
Full name of responsible person - English: Hassan Salehi Moghaddam
Full name of responsible person - Persian: حسن صالحی مقدم
Street address - English: No 6, RITAC center, Keshvari avenue, Banihashem square
Street address - Persian: میدان بنی هاشم، خیابان کشوری، پلاک 6، مرکز رشد زیست فناوری رویان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1665813339
Phone: +98 21 2233 8248
Fax:
Email: kiacell.immune@gmail.com
Web page address: https://kiacell-immune.com
contact.organization_id: Name of organization / entity - English: Kian Immune Cell company Name of organization / entity - Persian: شرکت کیان ایمن سلول Full name of responsible person - English: Hassan Salehi Moghaddam Full name of responsible person - Persian: حسن صالحی مقدم Street address - English: No 6, RITAC center, Keshvari avenue, Banihashem square Street address - Persian: میدان بنی هاشم، خیابان کشوری، پلاک 6، مرکز رشد زیست فناوری رویان City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1665813339 Phone: +98 21 2233 8248 Fax: Email: kiacell.immune@gmail.com Web page address: https://kiacell-immune.com
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Yes
1
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90
90
empty
Private
private
empty
Domestic
domestic
empty
Industry
industry
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Kian Immune Cell company
Kian Immune Cell company
empty
شرکت کیان ایمن سلول
شرکت کیان ایمن سلول
Protocol summary
Study aim
Evaluation the safety of intrathecal injection of activated allogenic NK cells in pediatrics with brain gliomas
Design
A phase I, open label, non control, non randomized trial in 10 eligible patients
Settings and conduct
Patients will be admitted to Rasoul Akram hospital and in period between end of radiotherapy and start of chemotherapy, or in intervals between chemotherapy courses will receive five injections. Five more injections will be planned in cases of response to the treatment.
Participants/Inclusion and exclusion criteria
patients with diagnosis of brain stem glioma, DIPG, unresectable glioma, and relapsed-refractory glioma which have the following inclusion criteria:
1. Age between 3 to 18 years old
2. Hemoglobin level above 10 gr/deciliter of blood
3. Absolute granulocyte count (AGC) above 1500 per microliter of blood
4. Platelet count above 100000 per microliter of blood
5. Lansky/Karnofsky performance score above 60
6. INR below 2 and PTT less than 1/5 times of maximum normal value
7. Plasma Bilirubin level less than 1/5 times of maximum normal value
8. Plasma hepatic transaminases (ALT and AST) level less than 2/5 times of maximum normal value
9. Plasma Creatinine level less than 1/5 times of maximum normal value
the exclusion criteria are:
1.evidence of radio necrosis in MRI or MRS
2. intolerance of new treatment due to emergency condition
3. rupture of cerebral shunt or unable to perform a lumbar puncture (LP)
4. history of other malignancies
5. history of any immunodeficiency diseases or any immune compromising conditions
6. occurrence of new neurologic lesion after first injection
Intervention groups
40-50 million activated allogenic NK cells will be injected intrathecally every week till five injection. In cases of response to the treatment, five more injections will be planned
Main outcome variables
Safety of intrathecal injection of NK cells
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170122032121N6
Registration date:2021-11-19, 1400/08/28
Registration timing:registered_while_recruiting
Last update:2022-10-22, 1401/07/30
Update count:1
Registration date
2021-11-19, 1400/08/28
Registrant information
Name
Marzieh Ebrahimi
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 23562516
Email address
mebrahimi@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-17, 1400/07/25
Expected recruitment end date
2022-10-22, 1401/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the safety of intrathecal injection of activated allogenic Natural Killer (NK) cells in pediatrics with brain gliomas; A phase I clinical trial
Public title
NK cell therapy in pediatrics with brain glioma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with diagnosis of brain stem glioma, DIPG, unresectable glioma, and relapsed-refractory glioma
Age between 3 to 18 years old
Hemoglobin level above 10 gr/deciliter of blood
Absolute granulocyte count (AGC) above 1500 per microliter of blood
Platelet count above 100000 per microliter of blood
Lansky (for under 16 years old) or Karnofsky (for above 16 years old) performance score above 60
INR below 2 and PTT less than 1/5 times of maximum normal value
Plasma Bilirubin level less than 1/5 times of maximum normal value
Plasma hepatic transaminases (ALT and AST) level less than 2/5 times of maximum normal value
Plasma Creatinine level less than 1/5 times of maximum normal value
Informed consent of parents or legal attendance
Exclusion criteria:
evidence of radio necrosis in MRI or MRS
intolerance of new treatment due to emergency condition
rupture of cerebral shunt or unable to perform a lumbar puncture (LP)
history of other malignancies
history of any immunodeficiency diseases or any immune compromising conditions
occurrence of new neurologic lesion after first injection
Safety of intrathecal injection of Natural Killer (NK) cells
Timepoint
safety will be measured after each injection till 24 hour in hospital for acute adverse events. Other adverse events will be recorded in periodical follow up in 1, 3, 6, and 12 month after the last injection
Method of measurement
Common Terminology Criteria for Adverse Events (CTCAEs) checklist
Secondary outcomes
1
Description
Change of tumor size
Timepoint
Tumor size will be measured before the first injection and after fifth and tenth injection it will be measured again. 3 month, 6 month and 12 month after the last injection the size will be measured ordinally.
Method of measurement
MRI (with and without contrast and DWI method) and MRS
2
Description
Overall survival and progression-free survival
Timepoint
At the end of the study the survivals will be measured for patients
Method of measurement
Kaplan-Meier method
3
Description
Cerebrospinal fluid (CSF) analysis (cytokine changes, hematology, and biochemistry)
Timepoint
Before each injection, samples of CSF will be taken and will sent to lab for analysis
Method of measurement
ELISA, Spectrophotometry, microscopic study
Intervention groups
1
Description
Intervention group: 40-50 million activated allogenic NK cells will be injected intrathecally every week till five injection. In cases of response to the treatment, five more injections will be planned.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Royan institute
Proportion provided by this source
10
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
2
Sponsor
Name of organization / entity
Kian Immune Cell company
Full name of responsible person
Hassan Salehi Moghaddam
Street address
No 6, RITAC center, Keshvari avenue, Banihashem square
City
Tehran
Province
Tehran
Postal code
1665813339
Phone
+98 21 2233 8248
Email
kiacell.immune@gmail.com
Web page address
https://kiacell-immune.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kian Immune Cell company
Proportion provided by this source
90
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Royan institute
Full name of responsible person
Hamid Mahdizadeh
Position
Research assistant
Latest degree
Medical doctor
Other areas of specialty/work
Immunology
Street address
Kian immune cell company, first floor, Royan RITAC center, Number 6, Keshvari alley, Banihashem square, Banihashem street, Resalat highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1665651911
Phone
009823562000
Email
mahdizadehmd@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Royan institute
Full name of responsible person
Hamid Mahdizadeh
Position
Research assistant
Latest degree
Medical doctor
Other areas of specialty/work
Immunology
Street address
Kian immune cell company, first floor, Royan RITAC center, Number 6, Keshvari alley, Banihashem square, Banihashem street, Resalat highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1665651911
Phone
009823562000
Email
mahdizadehmd@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Royan institute
Full name of responsible person
Hamid Mahdizadeh
Position
Research assistant
Latest degree
Medical doctor
Other areas of specialty/work
Immunology
Street address
Kian immune cell company, first floor, Royan RITAC center, Number 6, Keshvari alley, Banihashem square, Banihashem street, Resalat highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1665651911
Phone
009823562000
Email
mahdizadehmd@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Not applicable
Title and more details about the data/document
After concealment of personal information of participants, data of eligibility, CRFs and measured outcomes can be shared in case of request.
When the data will become available and for how long
After publishing results in a scientific journal with no deadline
To whom data/document is available
Just to academic PIs
Under which criteria data/document could be used
Any usage of data should be consulted and approved by the PIs (Dr.Ebrahimi and Dr.Faranoush)
From where data/document is obtainable
Applicant should send an e-mail to Dr.Mahdizadeh and propose their detailed requirements of the study data
What processes are involved for a request to access data/document
After sending an e-mail to Dr.Mahdizadeh, he will assess the authenticity of the applicant in almost 2 weeks. Then he will plan a meeting (visual or attendance) for the applicant with Dr.Ebrahimi and Dr.Faranoush in next month. The applicant can obtain approval of data sharing in this meeting and the data will be sent in next 14 days.