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Nk Cell Therapy for Recurrent Glioblastoma Multiform Patients

Primary Purpose

Glioblastoma Multiform, Recurrent Glioblastoma

Status

Unknown status

Phase

Phase 1

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

NK cell therapy

About this trial

This is an interventional treatment trial for Glioblastoma Multiform focused on measuring Natural Killer Cells (NK), Glioblastoma Multiform (GBM)

Eligibility Criteria

3 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Royan instituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Test group

Arm Description

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

Outcomes

Primary Outcome Measures

Toxicity assay

Toxicity as assessed by NCI CTCAE version 3.0

Adverse Events (AEs)

Defined as the number and severity of adverse events

Safety evaluation

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

Safety evaluation

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

Safety evaluation

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

MRI and MRS from the tumor region

Defined tumoral residua and tumor cell recurrence

Secondary Outcome Measures

Patient survival

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

Full Information

NCT ID

NCT05108012

First Posted

August 18, 2020

Last Updated

November 13, 2021

Sponsor

Royan Institute

Collaborators

Tehran University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT05108012

Brief Title

Nk Cell Therapy for Recurrent Glioblastoma Multiform Patients

Official Title

The Safety Evaluation of Ex Vivo Activated Haploidentical Natural Killer Cells (NK) in Recurrent Glioblastoma Multiform Patients (Clinical Trial Phase I)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2021 (Actual)

Primary Completion Date

November 2021 (Anticipated)

Study Completion Date

April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Royan Institute

Collaborators

Tehran University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma Multiform, Recurrent Glioblastoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Test group

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

NK cell therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Toxicity assay

Description

Toxicity as assessed by NCI CTCAE version 3.0

Time Frame

4 weeks of last injection

Title

Adverse Events (AEs)

Description

Defined as the number and severity of adverse events

Time Frame

1 year

Title

Safety evaluation

Description

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

Time Frame

From injection time point up to 48 hours

Title

Safety evaluation

Description

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

Time Frame

2 months after injection

Title

Safety evaluation

Description

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

Time Frame

From injection time point up to 8 weeks

Title

MRI and MRS from the tumor region

Description

Defined tumoral residua and tumor cell recurrence

Time Frame

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

Secondary Outcome Measure Information:

Title

Patient survival

Description

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

Time Frame

After surgery up to an average of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marzieh Ebrahimi, PhD

Phone

+98 21 235 62516

marzieh.ebrahimi@gmail.com;mebrahimi@royan-rc.ac.ir

First Name & Middle Initial & Last Name or Official Title & Degree

Zohreh Habibi, M.D

Phone

+98 912 336 5598

z-habibi@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Niloufar Shayan Asl, MSc

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Monire Mohammad, MSc

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Amirali Hamidieh, MD,PhD

Organizational Affiliation

Pediatric cell therapy research center, Tehran University of Medical Sciences

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marzieh Ebrahimi, PhD

Organizational Affiliation

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

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Zohreh Habibi, M.D

Organizational Affiliation

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

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Abolhossein Shahverdi, PhD

Organizational Affiliation

Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran

Official's Role

Study Chair

Facility Information:

Facility Name

Royan institute

City

Tehran

ZIP/Postal Code

Postal code:1665659911

Country

Iran, Islamic Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Niloufar Shayan Asl, MSc

Phone

+98 21 23 56 25 21

niloufar.shayanasl@gmail.com

First Name & Middle Initial & Last Name & Degree

Monire Mohammad, MSc

Phone

+98 21 23 56 25 21

monirmohamad@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

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Nk Cell Therapy for Recurrent Glioblastoma Multiform Patients

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