NCT05108012

Nk Cell Therapy for Recurrent Glioblastoma Multiform Patients

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Royan Institute · Other Government
• Sex: All
• Age: 3 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma Multiform
• Recurrent Glioblastoma

Interventions

Type	Name	Description
BIOLOGICAL	NK cell therapy	Activated NK cell injection in tumor cavity of patient with GBM (Glioblastoma Multiform)

Timeline

• Start date: 2021-08-01
• Primary completion: 2021-11-01
• Completion: 2022-04-01
• First posted: 2021-11-04
• Last updated: 2021-11-22

Locations

1 site across 1 country: Iran