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Nk cell therapy for recurrent GBM (Glioblastoma Multiform)

: The Safety Evaluation of Ex vivo Activated Haploidentical Natural Killer Cells (NK) in patients with Recurrent Glioblastoma Multiform and resistant/recurrent malignant brain tumor (Clinical Trial Phase I)

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20170122032121N5
Enrollment
5
Registered
2020-06-11
Start date
2020-07-10
Completion date
Unknown
Last updated
2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Glioblastoma Multiform(GBM) and resistant/recurrent malignant brain tumor. Malignant neoplasm of brain, unspecified

Interventions

Intervention group: 5 patients with recurrent glioblastoma and resistant/recurrent malignant brain tumor are included in the study according to the inclusion criteria. The peripheral blood of one pare

Sponsors

Iranian academic center for education culture and research
Lead Sponsor
Parsian Lotus Investment Bank
Collaborator

Eligibility

Sex/Gender
All
Age
3 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age: 3-65 Year Sex: Both Lansky/Karnofsky performance statue: 7-100% Life span expectation: >6 months Hemoglobin: > 10.0 g/dL AGC > 1,500/mm³ 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

Exclusion criteria

Exclusion criteria: Patients whose MRI or MRS view of the brain is in favor of radio necrosis Due to emergency conditions, the patient can not tolerate the new treatment Insufficient number of NK cells produced for treatment appearance new neurological ulcers after the first injection (after the wound heals, subsequent injections will be given if the patient is in good condition) diagnosis of any other invasive cancer within the past 5 years. Closing the reservare for the next injection (if this problem is solved, the injections will be done again. concurrent serious medical or psychiatric illness that may interfere with giving informed consent or conducting this study

Design outcomes

Primary

MeasureTime frame
Fever. Timepoint: After cell injection, every 2 hours up to 48 hours after cell injection. Method of measurement: Fever meter.;Hysteria. Timepoint: After cell injection, control the symptom up to 48 hours. Method of measurement: Patient checkup.;New neurological symptoms which not related to the tumor. Timepoint: Up to 48 hours after surgery, up to one week after cell injection. Method of measurement: Physical examination and recording of symptoms.

Secondary

MeasureTime frame
Tumor size. Timepoint: One week after injection, every 2 weeks up to 3 months. Method of measurement: MRI and MRS.;Patient's survival. Timepoint: Every month up to 6 months. Method of measurement: Communicate with patients.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNiloufar Shayan Asl

Iranian academic center for education culture and research

niloufar.shayanasl@gmail.com+98 21 2356 2521

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026