Nk Cell Therapy for Recurrent Glioblastoma Multiform Patients

NCT05108012 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2021-11-22

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

NK cell therapy

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

Sponsors & Collaborators

  • Tehran University of Medical Sciences

    collaborator OTHER
  • Royan Institute

    lead OTHER_GOV

Principal Investigators

  • Niloufar Shayan Asl, MSc · Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran

  • Monire Mohammad, MSc · Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran

  • Amirali Hamidieh, MD,PhD · Pediatric cell therapy research center, Tehran University of Medical Sciences

  • Marzieh Ebrahimi, PhD · Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran

  • Zohreh Habibi, M.D · Children's Hospital Medical Center, Tehran University of Medical Science, Tehran, Iran

  • Abolhossein Shahverdi, PhD · Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2021-11-30
Completion
2022-04-30

Countries

  • Iran

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05108012 on ClinicalTrials.gov