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Nk Cell Therapy for Recurrent Glioblastoma Multiform Patients

NCT ID: NCT05108012

Last Updated: 2021-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-04-30

Brief Summary

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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

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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

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Glioblastoma Multiform Recurrent Glioblastoma

Keywords

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Natural Killer Cells (NK) Glioblastoma Multiform (GBM)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Test group

The investigators will inject the activated NK cells, 1-3 times with weekly interval into tumor cavity.

Group Type EXPERIMENTAL

NK cell therapy

Intervention Type BIOLOGICAL

Activated NK cell injection in tumor cavity of patient with GBM (Glioblastoma Multiform)

Interventions

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NK cell therapy

Activated NK cell injection in tumor cavity of patient with GBM (Glioblastoma Multiform)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Exclusion Criteria

* 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).
Minimum Eligible Age

3 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role collaborator

Royan Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Niloufar Shayan Asl, MSc

Role: PRINCIPAL_INVESTIGATOR

Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran

Monire Mohammad, MSc

Role: PRINCIPAL_INVESTIGATOR

Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran

Amirali Hamidieh, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Pediatric cell therapy research center, Tehran University of Medical Sciences

Marzieh Ebrahimi, PhD

Role: STUDY_DIRECTOR

Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran

Zohreh Habibi, M.D

Role: STUDY_DIRECTOR

Children's Hospital Medical Center, Tehran University of Medical Science, Tehran, Iran

Abolhossein Shahverdi, PhD

Role: STUDY_CHAIR

Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran

Locations

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Royan institute

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Marzieh Ebrahimi, PhD

Role: CONTACT

Phone: +98 21 235 62516

Email: [email protected];[email protected]

Zohreh Habibi, M.D

Role: CONTACT

Phone: +98 912 336 5598

Email: [email protected]

Facility Contacts

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Niloufar Shayan Asl, MSc

Role: primary

Monire Mohammad, MSc

Role: backup

Other Identifiers

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GMB1

Identifier Type: -

Identifier Source: org_study_id