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Cell Therapy
NK Cell Therapy for Pediatric Brain Cancer (PNOC028 Trial)
Phase 1
Waitlist Available
Research Sponsored by Sabine Mueller, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from initiation of study treatment until 30 days from the end of therapy, approximately 1 year
Awards & highlights
PNOC028 Trial Summary
This trial tests if giving natural killer cells from healthy donors can safely and effectively treat brain cancer in children and young adults.
Who is the study for?
This trial is for children and young adults aged 1 to 39 with recurrent or progressive non-metastatic brain tumors (WHO Grade III/IV). They must have completed initial treatments, be fit for surgery to place an Ommaya reservoir, and not be on chronic steroids. Participants need proper organ function, a performance score of at least 50, and agree to use contraception. Excluded are those with immune disorders, severe illnesses, bleeding risks, pregnancy/breastfeeding or unstable conditions.Check my eligibility
What is being tested?
The trial tests the safety and optimal dosage of NK cells from universal donors in treating malignant brain tumors that have returned after treatment. These NK cells are designed to fight tumor cells by being injected directly into the tumor site using an implanted reservoir.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system's response such as inflammation around the injection site or general flu-like symptoms. There could also be risks associated with surgical implantation of the Ommaya reservoir.
PNOC028 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from initiation of study treatment until 30 days from the end of therapy, approximately 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from initiation of study treatment until 30 days from the end of therapy, approximately 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants with treatment-emergent adverse events
Recommended Phase II dose (RP2D)
PNOC028 Trial Design
3Treatment groups
Experimental Treatment
Group I: Dose Level 4 (3x10^8/m^2)Experimental Treatment2 Interventions
If no safety or toxicity events are demonstrated by the previous dose cohort, enrolled patients in the next dosing cohort must proceed to surgery for tumor resection and Ommaya placement into the resection cavity within 14 days of enrollment. The dose of 3x10^8/m^2 of TGFβi NK cells (first dose) may be administered at least 14 days after the Ommaya reservoir placement, and may not start until all acute surgical complications have resolved (maximum of 6 weeks after enrollment). TGFβi NK cell infusions through the Ommaya reservoir will occur once weekly for three weeks followed by one rest week. If patients have stable or improved disease, patients may continue to receive therapy for a total of 12 cycles.
Group II: Dose Level 3 (3x10^7/m^2)Experimental Treatment2 Interventions
If no safety or toxicity events are demonstrated by the starting dose cohort, enrolled patients in the next dosing cohort must proceed to surgery for tumor resection and Ommaya placement into the resection cavity within 14 days of enrollment. The dose of 3x10^7/m^2 of TGFβi NK cells (first dose) may be administered at least 14 days after the Ommaya reservoir placement, and may not start until all acute surgical complications have resolved (maximum of 6 weeks after enrollment). TGFβi NK cell infusions through the Ommaya reservoir will occur once weekly for three weeks followed by one rest week. If patients have stable or improved disease, patients may continue to receive therapy for a total of 12 cycles.
Group III: Dose Level 2 (3x10^6/m^2) - Starting DoseExperimental Treatment2 Interventions
Enrolled patients must proceed to surgery for tumor resection and Ommaya placement into the resection cavity within 14 days of enrollment. Starting dose of 3x10^6/m^2 of TGFβi NK cells (first dose) may be administered at least 14 days after the Ommaya reservoir placement, and may not start until all acute surgical complications have resolved (maximum of 6 weeks after enrollment). TGFβi NK cell infusions through the Ommaya reservoir will occur once weekly for three weeks followed by one rest week. If patients have stable or improved disease, patients may continue to receive therapy for a total of 12 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Implantation
2016
Completed Phase 4
~240
Find a Location
Who is running the clinical trial?
Sabine Mueller, MD, PhDLead Sponsor
8 Previous Clinical Trials
459 Total Patients Enrolled
Nationwide Children's HospitalOTHER
341 Previous Clinical Trials
5,220,479 Total Patients Enrolled
Rally FoundationUNKNOWN
1 Previous Clinical Trials
8,000 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a bleeding disorder or am taking blood thinners.I have a health condition that prevents me from having surgery.I am mostly able to carry out daily activities.My cancer has spread to other parts of my body.My tumor needs direct treatment through injection or special access.I am only having needle biopsies for my condition.I am not pregnant or breastfeeding.I have finished my first round of treatment with radiation or chemotherapy.My kidney, liver, bone marrow, and brain functions are within normal ranges.I am on long-term corticosteroid medication.My brain tumor is aggressive and has come back or gotten worse, but hasn't spread.I am between 8 and 39 years old.I am between 1 and 38 years old.I have recovered from side effects of my previous cancer treatment.I have completed all my previous cancer treatments within the required time frames.I do not have any severe infections or unstable health conditions.I am eligible for surgery to remove or biopsy my recurring tumor and can have an Ommaya reservoir placed.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Level 3 (3x10^7/m^2)
- Group 2: Dose Level 4 (3x10^8/m^2)
- Group 3: Dose Level 2 (3x10^6/m^2) - Starting Dose
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age threshold for enrollment in this investigation above thirty years?
"The parameters for this trial only accept individuals between one year and thirty-nine. There are 468 studies that cater to minors, while 3447 trials focus on seniors aged 65 or above."
Answered by AI
Has the FDA confirmed approval of Dose Level 2 (3x10^6/m^2) - Starting Dose?
"Due to the limited information regarding the safety and efficacy of Dose Level 2 (3x10^6/m^2) - Starting Dose, our team at Power judged it a score of 1."
Answered by AI
What criteria must individuals meet in order to be accepted into this medical experiment?
"Entry to this experimental study necessitates a diagnosis of brain tumor and an age between one year old and 39 years old. A total of 24 individuals are planned for recruitment into the trial."
Answered by AI
Are there any openings to join this experiment at present?
"Based on the information available through clinicaltrials.gov, this trial is not presently open to participants. It was initially posted on July 1st 2023 and last updated 24th May 2023. Despite that, there are currently 3764 other studies actively searching for qualified candidates."
Answered by AI
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