Glioblastoma MultiformPhase 1NCT05108012
Nk Cell Therapy for Recurrent Glioblastoma Multiform Patients
A Phase 1 study testing NK cell therapy in people with Glioblastoma Multiform and Recurrent Glioblastoma, run by Royan Institute at 1 site in Iran.
Trial summary
Glioblastoma multiform is one of the most invasive and deadly cancers that progresses rapidly and leads to death. Surgery with radiotherapy /chemotherapy, as a treatment approach is ineffective in some cases and is associated with relapse and death. Read more about this study
- Who is it for?
- Ages 3 to 60 years
- Conditions the study is for
- Glioblastoma Multiform, Recurrent Glioblastoma
- What is being tested?
- NK cell therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIran
- Study dates
- 1 Aug 2021to Apr 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- Patients whose MRI and MRS images is in favor of radio necrosis.
- Due to emergency conditions, the patient cannot tolerate the new treatment
- Lack of a suitable donor or insufficient number of NK cells.
- Development of a new neurological defect after the first injection
- Patient death during surgery
- Closing the reservoir for the next injection (if this problem is resolved, the injections will be done again).
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Royan institute
Tehran, Postal code:1665659911
Niloufar Shayan Asl, MSc, +98 21 23 56 25 21, niloufar.shayanasl@gmail.com
Monire Mohammad, MSc, +98 21 23 56 25 21, monirmohamad@yahoo.com
About this study
Official title: The Safety Evaluation of Ex Vivo Activated Haploidentical Natural Killer Cells (NK) in Recurrent Glioblastoma Multiform Patients (Clinical Trial Phase I)
Glioblastoma multiform is one of the most invasive and deadly cancers that progresses rapidly and leads to death. Surgery with radiotherapy /chemotherapy, as a treatment approach is ineffective in some cases and is associated with relapse and death. Immunotherapy is a special strategy that used as an adjunct therapy in various cancers and among the various methods of immunotherapy; it seems that cell therapy with NK cells is of special importance. A previous study conducted at the Royan Research Institute showed that NK cell proliferation and amplification resulted in the removal of glioblastoma tumor masses in the animal model. The animals had no evidence of tumor recurrence after treatment, and all tumor-related complications resolved after treatment. Therefore, in this study, the investigators intend to evaluate the safety of ex vivo activated cells in 5 patients with glioblastoma multiform whose disease has returned after treatment and who have not had any appropriate treatment.
Read the detailed description
1- patient selection 2- leukapheresis 3- CD56+ cells isolation 4- NK cells activation 5- assessment of functionality and purity 6- quality control tests 7-NK cell injection in tumor cavity.
- Conditions
- Glioblastoma Multiform, Recurrent Glioblastoma
- Being tested
- NK cell therapy
- Keywords
- Natural Killer Cells (NK), Glioblastoma Multiform (GBM)
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK cell therapyBiological
Activated NK cell injection in tumor cavity of patient with GBM (Glioblastoma Multiform)
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | The investigators will inject the activated NK cells, 1-3 times with weekly interval into tumor cavity. Receives: Biological: NK cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity assay
Toxicity as assessed by NCI CTCAE version 3.0
Measured: 4 weeks of last injection
Adverse Events (AEs)
Defined as the number and severity of adverse events
Measured: 1 year
Safety evaluation
Safety evaluated by assessing the medical symptoms measurement: Fever, Hysteria and Convulsion
Measured: From injection time point up to 48 hours
Safety evaluation
Safety evaluated by assessing the medical symptoms measurement: Meningitis, Neurological disorders
Measured: 2 months after injection
Safety evaluation
Safety evaluated by assessing the medical symptoms measurement: Loss of consciousness
Measured: From injection time point up to 8 weeks
MRI and MRS from the tumor region
Defined tumoral residua and tumor cell recurrence
Measured: 1 months after last dose of NK cell injection up to 1 year each 3 months
Secondary outcomes (1)
Patient survival
Evaluation of patient's life extension followed by NK cell therapy
Measured: After surgery up to an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start1 Aug 2021
- Primary completionNov 2021 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The investigators will enroll 5 patients (3-60 year, both sex, -Lansky performance scale/Karnofsky performance scale: 70-100%) with recurrent Glioblastoma Multiform. A haploidentical donor will enter for each patient.
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Collaborators
- Tehran University of Medical Sciences
- Responsible party
- Sponsor
- Investigators
- Niloufar Shayan Asl, MSc, Principal investigator, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, IranMonire Mohammad, MSc, Principal investigator, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, IranAmirali Hamidieh, MD,PhD, Principal investigator, Pediatric cell therapy research center, Tehran University of Medical SciencesMarzieh Ebrahimi, PhD, Study director, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, IranZohreh Habibi, M.D, Study director, Children's Hospital Medical Center, Tehran University of Medical Science, Tehran, IranAbolhossein Shahverdi, PhD, Study chair, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108012
- Sponsor's protocol ID
- GMB1
- Status last verified
- Oct 2021
- First submitted
- 18 Aug 2020
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety Evaluation of Ex Vivo Activated Haploidentical Natural Killer Cells (NK) in Recurrent Glioblastoma Multiform Patients (Clinical Trial Phase I)
- ClinicalTrials.gov ID
- NCT05108012
- Acronym / sponsor ID
- GMB1
- Conditions
- Glioblastoma Multiform, Recurrent Glioblastoma
- Keywords
- Natural Killer Cells (NK), Glioblastoma Multiform (GBM)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Royan InstituteOther government
- Collaborators
- Tehran University of Medical Sciences
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 4 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Glioblastoma multiform is one of the most invasive and deadly cancers that progresses rapidly and leads to death. Surgery with radiotherapy /chemotherapy, as a treatment approach is ineffective in some cases and is associated with relapse and death. Immunotherapy is a special strategy that used as an adjunct therapy in various cancers and among the various methods of immunotherapy; it seems that cell therapy with NK cells is of special importance. A previous study conducted at the Royan Research Institute showed that NK cell proliferation and amplification resulted in the removal of glioblastoma tumor masses in the animal model. The animals had no evidence of tumor recurrence after treatment, and all tumor-related complications resolved after treatment. Therefore, in this study, the investigators intend to evaluate the safety of ex vivo activated cells in 5 patients with glioblastoma multiform whose disease has returned after treatment and who have not had any appropriate treatment.
Detailed description
1- patient selection 2- leukapheresis 3- CD56+ cells isolation 4- NK cells activation 5- assessment of functionality and purity 6- quality control tests 7-NK cell injection in tumor cavity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The investigators will enroll 5 patients (3-60 year, both sex, -Lansky performance scale/Karnofsky performance scale: 70-100%) with recurrent Glioblastoma Multiform. A haploidentical donor will enter for each patient.
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Biological: NK cell therapyThe investigators will inject the activated NK cells, 1-3 times with weekly interval into tumor cavity. |
Who may qualify
- Ages
- 3 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Patients whose MRI and MRS images is in favor of radio necrosis.
- Due to emergency conditions, the patient cannot tolerate the new treatment
- Lack of a suitable donor or insufficient number of NK cells.
- Development of a new neurological defect after the first injection
- Patient death during surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NK cell therapyActivated NK cell injection in tumor cavity of patient with GBM (Glioblastoma Multiform) | Biological | Test group |
Primary outcome
Toxicity assay
Time frame: 4 weeks of last injection
Toxicity as assessed by NCI CTCAE version 3.0
Adverse Events (AEs)
Time frame: 1 year
Defined as the number and severity of adverse events
Safety evaluation
Time frame: From injection time point up to 48 hours
Safety evaluated by assessing the medical symptoms measurement: Fever, Hysteria and Convulsion
Safety evaluation
Time frame: 2 months after injection
Safety evaluated by assessing the medical symptoms measurement: Meningitis, Neurological disorders
Safety evaluation
Time frame: From injection time point up to 8 weeks
Safety evaluated by assessing the medical symptoms measurement: Loss of consciousness
MRI and MRS from the tumor region
Time frame: 1 months after last dose of NK cell injection up to 1 year each 3 months
Defined tumoral residua and tumor cell recurrence
1 secondary outcome
Patient survival
Time frame: After surgery up to an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niloufar Shayan Asl, MSc principal investigator
Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran
Monire Mohammad, MSc principal investigator
Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran
Amirali Hamidieh, MD,PhD principal investigator
Pediatric cell therapy research center, Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NK cell therapy in people with Glioblastoma Multiform and Recurrent Glioblastoma, run by Royan Institute at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marzieh Ebrahimi, PhD (+98 21 235 62516, marzieh.ebrahimi@gmail.com;mebrahimi@royan-rc.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity assay (time frame: 4 weeks of last injection). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.