Nk Cell Therapy for Recurrent Glioblastoma Multiform Patients

NCT05108012 | Unknown Phase 1 DMC

• 1 other identifier: GMB1
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Glioblastoma Multiform; Recurrent Glioblastoma

Keywords

Natural Killer Cells (NK); Glioblastoma Multiform (GBM)

Outcome Measures

Primary Outcomes (6)

• Toxicity assay

  Toxicity as assessed by NCI CTCAE version 3.0

  4 weeks of last injection

• Adverse Events (AEs)

  Defined as the number and severity of adverse events

  1 year

• Safety evaluation

  Safety evaluated by assessing the medical symptoms measurement: Fever, Hysteria and Convulsion

  From injection time point up to 48 hours

• Safety evaluation

  Safety evaluated by assessing the medical symptoms measurement: Meningitis, Neurological disorders

  2 months after injection

• Safety evaluation

  Safety evaluated by assessing the medical symptoms measurement: Loss of consciousness

  From injection time point up to 8 weeks

• MRI and MRS from the tumor region

  Defined tumoral residua and tumor cell recurrence

  1 months after last dose of NK cell injection up to 1 year each 3 months

Secondary Outcomes (1)

• Patient survival

  After surgery up to an average of 1 year

Study Arms (1)

Test group

EXPERIMENTAL

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

Biological: NK cell therapy

Interventions

NK cell therapy BIOLOGICAL

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

Test group

Eligibility Criteria

• Age: 3 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Royan Institute: lead
• Tehran University of Medical Sciences: collaborator

Study Sites (1)

Royan institute

Tehran, Postal code:1665659911, Iran

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Niloufar Shayan Asl, MSc

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

  PRINCIPAL INVESTIGATOR

• Monire Mohammad, MSc

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

  PRINCIPAL INVESTIGATOR

• Amirali Hamidieh, MD,PhD

  Pediatric cell therapy research center, Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Marzieh Ebrahimi, PhD

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

  STUDY DIRECTOR

• Zohreh Habibi, M.D

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

  STUDY DIRECTOR

• Abolhossein Shahverdi, PhD

  Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran

  STUDY CHAIR

Central Study Contacts

Marzieh Ebrahimi, PhD

CONTACT

+98 21 235 62516; marzieh.ebrahimi@gmail.com;mebrahimi@royan-rc.ac.ir

Zohreh Habibi, M.D

CONTACT

+98 912 336 5598; z-habibi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: November 4, 2021
• Study Start: August 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: April 1, 2022
• Last Updated: November 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)