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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

NK HGG Trial Summary

This trial will test a new cancer treatment involving infusions of natural killer cells. Patients will receive the infusions over 12 weeks, with each cycle consisting of 1 infusion per week for 3 weeks, followed by a rest week. The dose will be escalated in an inter-patient stepwise fashion, consisting of 4 dose levels.

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.Check my eligibility
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.See study design
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.

NK HGG Trial 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.

NK HGG Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events from NK cells
Maximum tolerated dose
Secondary outcome measures
Overall survival
Other outcome measures
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

NK HGG 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

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor
341 Previous Clinical Trials
5,220,479 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial open to those of advanced age?

"This medical experiment is seeking participants aged between 3 and 17 years old."

Answered by AI

How many individuals are participating in this trial?

"At this time, no further participants are being accepted for this medical trial. The study was initially posted on the 1st of July 2022 and the latest update happened on November 11th 2022. If you're interested in other trials, there are currently 357 glioma studies actively enrolling patients as well as 30 clinical trials for NK cells admitting new participants."

Answered by AI

What other studies have been conducted centering around Natural Killer cells?

"Presently, 30 clinical trials focusing on NK cells are being conducted. None of these studies have yet entered Phase 3. The majority of them take place in Wuxi, Jiangsu; however, 43 different medical sites worldwide are running relevant experiments."

Answered by AI

Does this clinical experiment have capacity to accept new participants?

"As indicated on clinicaltrials.gov, this study is not currently enrolling participants at the moment. The trial was uploaded on July 1st 2022 and revised lastly on January 11th 2022; however, 387 other trials are actively recruiting patients now."

Answered by AI

To what extent could NK cells be detrimental to human health?

"As this is a Phase 1 study, the safety of NK cells was deemed to be comparatively low with a score of one. This rating accounts for reduced evidence in support of their efficacy and security."

Answered by AI

Is it feasible for me to partake in this medical trial?

"The age range for acceptance into the trial is from 3 to 17, and participants must be diagnosed with glioma. 24 patients are required for successful completion of this clinical study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Intra-tumoral Injection of Natural Killer Cells in High-Grade Gliomas
2023. "Intra-tumoral Injection of Natural Killer Cells in High-Grade Gliomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04254419.
~12 spots leftby Oct 2024
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