← Back to Search

Cell Therapy

NK Cell Therapy for Brain Cancer (NK HGG Trial)

Phase 1
Waitlist Available
Led By Mohamed S AbdelBaki, MD
Research Sponsored by Nationwide Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have a histologically-confirmed recurrent non-metastatic supratentorial WHO Grade III malignant glioma or WHO Grade IV malignant glioma
Adequate liver function (ALT, AST, and alkaline phosphatase < 2 times ULN, bilirubin < 1.5 times ULN) and adequate renal function (BUN or creatinine < 1.5 times ULN) prior to NK cell
Must not have
Tumor involvement that would require ventricular, brainstem, or posterior fossa injection or access through a ventricle or risk of ventricular penetration in order to deliver the NK cells
Tumors involving both hemispheres or those involving the subependyma or suspected CSF dissemination
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
No Placebo-Only Group

Summary

This trial involves giving patients special immune cells called NK cells through an infusion. It targets patients who may not respond well to standard treatments. The goal is to enhance the body's ability to fight harmful cells by increasing the number of NK cells. NK cells have attracted attention as a promising cancer immunotherapeutic target due to their ability to kill malignant cells and avoid healthy cells.

Who is the study for?
This trial is for children and teens (3-18 years old) with high-grade, recurrent brain tumors who've had prior radiation treatment. They must be healthy enough for surgery, have good organ function, not be on steroids or certain other medications, and agree to use birth control if applicable.
What is being tested?
The study tests the safety and effects of injecting Natural Killer (NK) cells directly into the tumor over 12 weeks. Patients will receive weekly infusions in cycles of three weeks with a rest week following each cycle. The NK cell dose increases stepwise between patients.
What are the potential side effects?
Potential side effects may include reactions at the injection site, fever, fatigue, allergic responses to NK cells or increased susceptibility to infections due to immune system interactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My brain tumor is a high-grade type but has not spread beyond the brain.
Select...
My liver and kidney functions are within normal limits.
Select...
It has been over 12 weeks since I finished my initial radiation therapy.
Select...
I am mostly active and can do things for myself, regardless of my age.
Select...
I haven't taken any steroids (except for replacement therapy) for 3 days before NK cell treatment.
Select...
I have completed my first round of treatment with 54 Gy of radiation.
Select...
I am eligible for surgery to remove or biopsy my recurring tumor and can have an Ommaya reservoir placed.
Select...
I am between 3 and 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My tumor cannot be safely accessed for NK cell therapy without risking brain damage.
Select...
My tumor affects both sides of my brain or has spread to the brain's lining.
Select...
I am on long-term steroid medication.
Select...
My cancer has spread to my brain or other parts of my body.
Select...
I have a health condition that prevents me from having surgery.
Select...
I do not have any severe infections or unstable health conditions.
Select...
I am not on medication that increases bleeding risk and do not have a bleeding disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events from NK cells
Maximum tolerated dose
Secondary study objectives
Overall survival
Other study objectives
Assessment of function of expanded NK cells for high-grade glioma patients
Assessment of the immune signature based profile
Assessment of the immuno-phenotype of expanded NK cells for high-grade glioma patients
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: NK cell infusionExperimental Treatment1 Intervention
For source PBMCs from the patient, up to 3ml/kg (maximum 150ml) of heparinized peripheral blood will be drawn. NK cell product will be manufactured by a GMP facility. Once the NK cell goes through the appropriate procedures, it will undergo a lot release testing and cryopreservation by day 14 for infusion. If NK cells fail to meet release criteria or are insufficient in number for the dose level assigned, collection of PBMCs may be repeated up to 2 additional times. Duration of study therapy is up to 12 weeks and nine doses of NK cells.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NK cells
2008
Completed Phase 2
~100

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for brain tumors, such as NK cell infusions, work by activating the immune system to target and kill cancer cells. NK cell infusions involve administering natural killer cells directly into the tumor, which can recognize and destroy cancer cells without needing prior sensitization. This targeted approach is crucial for brain tumor patients as it aims to eliminate cancer cells while minimizing damage to healthy tissue, potentially reducing the side effects associated with conventional treatments like chemotherapy and radiation.
Immunopathogenesis of endometriosis: An overview of the role of innate and adaptive immune cells and their mediators.Chimeric antigen receptor T cell targeting B cell maturation antigen immunotherapy is promising for multiple myeloma.

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor
348 Previous Clinical Trials
5,228,508 Total Patients Enrolled
Mohamed S AbdelBaki, MDPrincipal InvestigatorNationwide Children's Hospital

Media Library

NK cells (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04254419 — Phase 1
Brain Tumor Research Study Groups: NK cell infusion
Brain Tumor Clinical Trial 2023: NK cells Highlights & Side Effects. Trial Name: NCT04254419 — Phase 1
NK cells (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04254419 — Phase 1
~13 spots leftby Oct 2025