What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for brain tumors include surgery, radiation therapy, and chemotherapy. Side effects of these treatments can vary but often include fatigue, nausea, hair loss, and cognitive changes. Treatments involving immune system activation, such as NK cell infusions, can lead to immune-related adverse events like inflammation, fever, and neurological complications. Targeted cell killing therapies may also cause specific organ toxicities depending on the treatment's mechanism of action.

What prior FDA approvals exist?

FDA approvals for brain tumor treatments have included various immunotherapy approaches. For instance, immune checkpoint inhibitors like nivolumab and pembrolizumab have been approved for certain types of brain tumors, leveraging the body's immune system to target and kill cancer cells. Additionally, CAR T-cell therapies, which involve modifying a patient's T cells to better recognize and attack cancer cells, have shown promise in clinical trials. These treatments are similar to the NK cell infusions being studied, as they both aim to enhance the immune system's ability to target and destroy tumor cells.

What other types of research exist?

Promising novel alternatives to NK Cell Infusions for brain tumor patients include: 1) Checkpoint inhibitors such as nivolumab and pembrolizumab, which have shown efficacy in various cancers including brain tumors. 2) CAR-T cell therapy, which involves modifying a patient's T cells to target cancer cells. 3) Oncolytic virus therapy, which uses genetically modified viruses to selectively infect and kill tumor cells. 4) Targeted therapies like lorlatinib and alectinib, which have shown brain penetration and efficacy in specific genetic subtypes of tumors. These therapies represent cutting-edge approaches that harness the immune system or target specific molecular pathways in cancer cells.

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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

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My brain tumor is a high-grade type but has not spread beyond the brain.

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My liver and kidney functions are within normal limits.

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It has been over 12 weeks since I finished my initial radiation therapy.

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I am mostly active and can do things for myself, regardless of my age.

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I haven't taken any steroids (except for replacement therapy) for 3 days before NK cell treatment.

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I have completed my first round of treatment with 54 Gy of radiation.

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I am eligible for surgery to remove or biopsy my recurring tumor and can have an Ommaya reservoir placed.

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I am between 3 and 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My tumor cannot be safely accessed for NK cell therapy without risking brain damage.

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My tumor affects both sides of my brain or has spread to the brain's lining.

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I am on long-term steroid medication.

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My cancer has spread to my brain or other parts of my body.

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I have a health condition that prevents me from having surgery.

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I do not have any severe infections or unstable health conditions.

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I am not on medication that increases bleeding risk and do not have a bleeding disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

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

0 / 15Eligibility criteria met

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.