Nk Cell Therapy for Recurrent Glioblastoma Multiform Patients

Recurrent Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05108012
• Other study ID #: GMB1
• Status: Recruiting
• Phase: Phase 1
• Start date: August 1, 2021
• Est. completion date: April 2022

Study information

• Verified date: October 2021
• Source: Royan Institute
• Contact: Marzieh Ebrahimi, PhD
• Phone: +98 21 235 62516
• Email: marzieh.ebrahimi[@]gmail.com;mebrahimi[@]royan-rc.ac.ir
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: April 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Glioblastoma
• Recurrent Glioblastoma

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan institute	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Royan Institute	Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity assay	Toxicity as assessed by NCI CTCAE version 3.0	4 weeks of last injection
Primary	Adverse Events (AEs)	Defined as the number and severity of adverse events	1 year
Primary	Safety evaluation	Safety evaluated by assessing the medical symptoms measurement: Fever, Hysteria and Convulsion	From injection time point up to 48 hours
Primary	Safety evaluation	Safety evaluated by assessing the medical symptoms measurement: Meningitis, Neurological disorders	2 months after injection
Primary	Safety evaluation	Safety evaluated by assessing the medical symptoms measurement: Loss of consciousness	From injection time point up to 8 weeks
Primary	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	Patient survival	Evaluation of patient's life extension followed by NK cell therapy	After surgery up to an average of 1 year