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CAR T-cell Therapy
GPC2 CAR T Cells for Neuroblastoma (GPC2 Trial)
Phase 1
Recruiting
Led By Lisa Wray, MD
Research Sponsored by Stephan Grupp MD PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new cancer treatment to see if it's safe for people with an advanced form of childhood cancer.
Who is the study for?
This trial is for patients over 1 year old with high-risk neuroblastoma that has come back or didn't respond to treatment. They must have a confirmed diagnosis, disease that can be measured, good organ function and performance status, and agree to use birth control if they can have children. People with active hepatitis B/C, HIV, uncontrolled infections or immune disorders, recent heart issues or vaccines cannot join.
What is being tested?
The trial is testing GPC2 CAR T cells in patients with advanced neuroblastoma. It's the first time this treatment is being used on humans and aims to find out how safe it is by gradually increasing the dose given to participants.
What are the potential side effects?
Possible side effects may include reactions related to the immune system such as Cytokine Release Syndrome (a rapid release of cytokines into the blood), which could lead to symptoms like fever and fatigue; neurotoxicity affecting brain functions; infection risks due to immunosuppression; and other complications not specified here.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Determine the Maximum Tolerated Dose of GPC2 CAR T cells
Frequency of Adverse Events Following GPC2 CAR T cell administration
Secondary study objectives
Manufacturing Feasibility of GPC2 CAR T cells
Persistence of GPC2 CAR T cells
Preliminarily define the clinical activity of GPC2 CAR T in patients with relapsed or refractory neuroblastoma
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Dose Expansion ArmExperimental Treatment1 Intervention
If at least one dose from the dose expansion arm is determined to be safe, additional patients will be enrolled to the dose expansion arm to preliminarily evaluate the rate of response to GPC2 CAR T cells and further characterize the safety profile of GPC2 CAR T cells.
Group II: Dose Escalation ArmExperimental Treatment1 Intervention
The dose escalation arm will determine the maximum tolerated dose of GPC2 CAR T cells using a standard 3+3 trial design.
Find a Location
Who is running the clinical trial?
Tmunity TherapeuticsIndustry Sponsor
6 Previous Clinical Trials
108 Total Patients Enrolled
University of PennsylvaniaOTHER
2,079 Previous Clinical Trials
42,721,591 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,018,008 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My neuroblastoma has come back or hasn't gone away after treatment.I have active hepatitis B or C.I have not received any live vaccines in the last 30 days.My organs are working well.My child's neuroblastoma is classified as high-risk.I am at least 1 year old.I do not have any uncontrolled infections.I do not have severe heart issues like recent heart attacks or uncontrolled heart rhythm problems.I have a condition that weakens my immune system.I am not on steroids or immunosuppressants that could affect cell therapy, except for certain allowed cases.I can do most activities but may need help.My cancer has spread to my brain and is getting worse.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Expansion Arm
- Group 2: Dose Escalation Arm
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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