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Genetically Modified T-Cells for Brain Cancer (PNOC018 Trial)
PNOC018 Trial Summary
This trial is testing the safety of a new treatment for brain cancer made from modified immune cells. The treatment will be given to patients who have a specific gene mutation and have not responded to other treatments.
PNOC018 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PNOC018 Trial Design
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Who is running the clinical trial?
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- I am a man who can father children and agree to use birth control and not donate sperm for 6 months after the study ends.My bilirubin levels are within the normal range for my age.I can sign the consent form and follow the study rules.My kidney function is within the normal range for my age and gender.I do not have any infections that are currently uncontrolled.I have had a solid organ or bone marrow transplant.I do not have trouble breathing when I am resting.I am not pregnant or breastfeeding.My cancer is located in the spinal cord.My MRI shows my tumor is not causing significant effects on surrounding areas.I am between 3 and 25 years old and can sign the consent form.I tested positive for HLA-A*0201 from a certified lab.I am mostly active and can care for myself.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.My seizures are well-managed with medication.I have taken a pregnancy test in the last 14 days and it was negative.I am not currently on any cancer treatments, except possibly bevacizumab for tumor swelling.I have not had a bone marrow transplant for my cancer.I haven't taken any steroids for at least 7 days.I can exercise without breathing problems.I can't return for follow-up visits or get tests to check therapy side effects.I have an immune system disorder but am not on strong immune-suppressing drugs.I have had cancer treatment other than radiation.I have a specific brain tumor with a certain mutation and have finished standard radiation therapy.My doctor says I have untreated water buildup in my brain causing symptoms.I am not on steroids, or I am on a stable dose of dexamethasone (up to 4 mg/day).I agree to follow the study's birth control advice for at least 6 months after the last treatment.My platelet count is at least 100,000/mm^3 without transfusions for 7 days.I started my standard radiation therapy within 6 weeks of my cancer diagnosis.
- Group 1: Treatment (KIND T cells, cyclophosphamide, fludarabine)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What are the eligibility requirements to partake in this research project?
"This clinical trial is seeking 12 individuals aged 3 to 21 with diffuse midline glioma and the h3 k27m mutation. Furthermore, candidates must meet certain criteria including testing positive for HLA-A*0201 (verified by CLIA or equivalent lab), consenting to tumor tissue analysis, being off systemic steroids or on a stable dose of dexamethasone at enrollment, etc. The first two participants will be over 12 years old; male patients of reproductive potential are expected to use contraception during treatment and refrain from donating sperm while female childbearing prospects should have had negative pregnancy tests prior to receiving study interventions."
Are Autologous Anti-H3.3K27M TCR-expressing T-cells a viable option for patients with regards to safety?
"The safety of Autologous Anti-H3.3K27M TCR-expressing T-cells is estimated to be a 1 due to its Phase 1 status, indicating that there is only preliminary evidence regarding efficacy and scant data on safety."
Could elderly individuals aged 60 and up qualify for this research?
"The conditions of this research program stipulate that the minimum age for enrollment is 3 and the maximum age must not exceed 21."
Are there still opportunities to partake in this clinical research?
"According to clinicaltrials.gov, this trial is not currently enrolling patients. The experiment was first published on January 1st 2023 and the most recent update took place November 7th 2022. There are 357 other trials actively recruiting at present, however this particular study is inactive in terms of recruitment."
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