Nk Cell Therapy for Recurrent Glioblastoma Multiform Patients

Sponsor
Royan Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05108012
Collaborator
Tehran University of Medical Sciences (Other)
5
1
1
8
0.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: NK cell therapy
Phase 1

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

Study Type:
Interventional
Anticipated Enrollment :
5 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
The Safety Evaluation of Ex Vivo Activated Haploidentical Natural Killer Cells (NK) in Recurrent Glioblastoma Multiform Patients (Clinical Trial Phase I)
Actual Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Test group

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

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

Outcome Measures

Primary Outcome Measures

  1. Toxicity assay [4 weeks of last injection]

    Toxicity as assessed by NCI CTCAE version 3.0

  2. Adverse Events (AEs) [1 year]

    Defined as the number and severity of adverse events

  3. Safety evaluation [From injection time point up to 48 hours]

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

  4. Safety evaluation [2 months after injection]

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

  5. Safety evaluation [From injection time point up to 8 weeks]

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

  6. MRI and MRS from the tumor region [1 months after last dose of NK cell injection up to 1 year each 3 months]

    Defined tumoral residua and tumor cell recurrence

Secondary Outcome Measures

  1. Patient survival [After surgery up to an average of 1 year]

    Evaluation of patient's life extension followed by NK cell therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Age: 3-60 Year -

  • Sex: Both

  • Lansky performance scale/Karnofsky performance scale: 70-100%

  • Life span expectation: >6 months

  • Hemoglobin: > 10.0 g/dl

  • Platelet count > 100,000/mm³

  • Serum total bilirubin < 1.5 times upper limit of normal (ULN)

  • ALT and AST < 2.5 times ULN

  • Serum creatinine < 1.5 times ULN

  • No diagnosis of any other invasive cancer within the past 5 years.

  • No concurrent serious medical or psychiatric illness that may interfere with giving informed consent or conducting this study

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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Royan institute Tehran Iran, Islamic Republic of Postal code:1665659911

Sponsors and Collaborators

  • Royan Institute
  • Tehran University of Medical Sciences

Investigators

  • Principal Investigator: 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
  • Study Director: 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 Chair: Abolhossein Shahverdi, PhD, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Royan Institute
ClinicalTrials.gov Identifier:
NCT05108012
Other Study ID Numbers:
  • GMB1
First Posted:
Nov 4, 2021
Last Update Posted:
Nov 22, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Royan Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 22, 2021