Nk Cell Therapy for Recurrent Glioblastoma Multiform Patients

Phase 1

• Conditions: Glioblastoma Multiform; Recurrent Glioblastoma
• Interventions: Biological: NK cell therapy

• Registration Number: NCT05108012
• Lead Sponsor: Royan Institute

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.

Study Timeline

• Study First Submitted: 2020-08-18
• Study Start: 2021-08-01
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-23
• Primary Completion: 2021-11
• Study First Posted: 2021-11-04
• Last Update Submitted: 2021-11-13
• Last Update Posted: 2021-11-22
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test group	NK cell therapy	The investigators will inject the activated NK cells, 1-3 times with weekly interval into tumor cavity.

Primary Outcome Measures

Name	Time	Method
Safety evaluation	From injection time point up to 8 weeks	Safety evaluated by assessing the medical symptoms measurement: Loss of consciousness
Adverse Events (AEs)	1 year	Defined as the number and severity of adverse events
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
Toxicity assay	4 weeks of last injection	Toxicity as assessed by NCI CTCAE version 3.0

Secondary Outcome Measures

Name	Time	Method
Patient survival	After surgery up to an average of 1 year	Evaluation of patient's life extension followed by NK cell therapy

Trial Locations

Locations (1)

Royan institute; 🇮🇷 Tehran, Iran, Islamic Republic of