cropped color_logo_with_background.png

Clinical Trial Finder

Nk Cell Therapy for Recurrent Glioblastoma Multiform Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 3 Years - 60 Years
Gender All
More Inclusion & Exclusion 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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05108012
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Royan Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Niloufar Shayan Asl, MScMonire Mohammad, MScAmirali Hamidieh, MD,PhDMarzieh Ebrahimi, PhDZohreh Habibi, M.DAbolhossein Shahverdi, PhD
Principal Investigator Affiliation Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, IranRoyan Institute for Stem Cell Biology and Technology, ACECR, Tehran, IranPediatric cell therapy research center, Tehran University of Medical SciencesRoyan Institute for Stem Cell Biology and Technology, ACECR, Tehran, IranChildren's Hospital Medical Center, Tehran University of Medical Science, Tehran, IranRoyan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Unknown status
Countries Iran, Islamic Republic of
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma Multiform, Recurrent Glioblastoma
Additional Details

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.

Arms & Interventions

Arms

Experimental: Test group

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

Interventions

Biological: - NK cell therapy

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Royan institute, Tehran, Iran, Islamic Republic of

Status

Recruiting

Address

Royan institute

Tehran, , Postal code:1665659911

Site Contact

Niloufar Shayan Asl, MSc

[email protected]

+98 21 23 56 25 21

Powered By