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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

GPC2 Trial 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.Check my eligibility
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.See study design
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.

GPC2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the Maximum Tolerated Dose of GPC2 CAR T cells
Frequency of Adverse Events Following GPC2 CAR T cell administration
Secondary outcome measures
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 more

GPC2 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
119 Total Patients Enrolled
University of PennsylvaniaOTHER
2,019 Previous Clinical Trials
42,874,116 Total Patients Enrolled
Stephan Grupp MD PhDLead Sponsor
4 Previous Clinical Trials
283 Total Patients Enrolled

Media Library

GPC2 CAR T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05650749 — Phase 1
Neuroblastoma Research Study Groups: Dose Expansion Arm, Dose Escalation Arm
Neuroblastoma Clinical Trial 2023: GPC2 CAR T cells Highlights & Side Effects. Trial Name: NCT05650749 — Phase 1
GPC2 CAR T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05650749 — Phase 1
~10 spots leftby Jan 2025
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