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CAR T-cell Therapy
Genetically Modified T-Cells for Brain Cancer (PNOC018 Trial)
Phase 1
Recruiting
Led By Sabine Mueller, MD, PhD, MAS
Research Sponsored by University of California, San Francisco
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 up to 24 months
Awards & highlights
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.
Who is the study for?
This trial is for HLA-A*0201-positive patients aged 3-21 with a specific brain tumor (H3.3K27M-mutated diffuse midline glioma) who've finished standard radiation therapy. They must not be pregnant, agree to use contraception, and have no immune disorders like HIV or hepatitis B/C. No prior treatments for the tumor are allowed.Check my eligibility
What is being tested?
The trial tests genetically modified KIND T cells after chemotherapy drugs cyclophosphamide and fludarabine in young patients with a certain type of brain cancer. It aims to find the safest dose and see how well these engineered T cells can target and fight the tumor.See study design
What are the potential side effects?
Potential side effects include reactions from the infusion of modified T cells, low blood cell counts due to chemotherapy, increased risk of infections, nausea, fatigue, and possible organ inflammation as an immune response.
PNOC018 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD)
Number of participants with treatment-emergent adverse events
Secondary outcome measures
Duration of KIND T cells in-vivo persistence
Percentage of participants who receive KIND T cells
PNOC018 Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (KIND T cells, cyclophosphamide, fludarabine)Experimental Treatment3 Interventions
Patients receive fludarabine IV on days -4, -3, and -2 and cyclophosphamide IV on day -2 in the absence of disease progression or unacceptable toxicity for the conditioning regimen. Patients also receive KIND T cells IV at dose level 1 (2 x 106 dextramer®+ CD8+ cells/kg) on day 0. If no DLTs are reported, newly enrolling participants may receive dose level 2 of KIND T cells on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1080
Cyclophosphamide
1995
Completed Phase 3
~3770
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
The most common treatments for Diffuse Midline Glioma (DMG) include radiation therapy and emerging immunotherapies like genetically modified T cells. Radiation therapy works by damaging the DNA of cancer cells, thereby inhibiting their ability to replicate and grow.
Genetically modified T cells, such as KIND T cells, are engineered to recognize and attack tumor-specific markers, enhancing the immune system's ability to target and destroy cancer cells. This approach is particularly significant for DMG patients because it offers a targeted treatment option that can potentially overcome the tumor's resistance to conventional therapies, providing a new avenue for managing this aggressive cancer.
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Who is running the clinical trial?
Alliance for Cancer Gene TherapyUNKNOWN
2 Previous Clinical Trials
55 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,522 Previous Clinical Trials
15,242,303 Total Patients Enrolled
The V FoundationOTHER
6 Previous Clinical Trials
157 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (KIND T cells, cyclophosphamide, fludarabine)
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.
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