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CAR T-cell Therapy

GD2 T-Cells + Chemotherapy for Neuroblastoma (VEGAS Trial)

Phase 1
Waitlist Available
Led By Cliona Rooney, PhD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Recovered from the acute toxic effects of all prior chemotherapy
Karnofsky/Lansky score of greater than or equal to 50
Must not have
Severe intercurrent infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights

Summary

This trial will study the largest safe dose of GD2-T cells in combination with a varicella zoster vaccine and lymphodepleting chemotherapy. The side effects of the treatment will also be studied.

Who is the study for?
This trial is for patients with relapsed or refractory osteosarcoma or high-risk neuroblastoma that hasn't responded to standard treatments. Participants must have a certain level of physical fitness, adequate organ function, and not be pregnant. They should have had prior exposure to the varicella zoster virus (chickenpox) or been vaccinated against it.
What is being tested?
The study tests a combination therapy using GD2-T cells genetically modified to target cancer cells, alongside lymohodepleting chemotherapy and a varicella zoster vaccine. The goal is to determine the highest safe dose of these T cells and assess their effectiveness in treating advanced sarcomas and neuroblastoma.
What are the potential side effects?
Potential side effects may include reactions from the immune system such as inflammation, symptoms related to chemotherapy like nausea and fatigue, possible allergic reactions to murine proteins in the treatment components, and risks associated with gene transfer.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have recovered from side effects of my previous cancer treatments.
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I am able to live with some level of independence.
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I have had chickenpox or received the chickenpox vaccine.
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My osteosarcoma or neuroblastoma has returned or didn't respond to standard treatments.
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My T cells are modified to target my cancer effectively.
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My liver, kidney functions, and blood counts are within the required ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have a severe ongoing infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of patients with dose limiting toxicity
Secondary study objectives
Amount of T cells in the blood after the infusions
Number of patients with a response to the T cells

Trial Design

1Treatment groups
Experimental Treatment
Group I: GD2 T cells plus VZV vaccineExperimental Treatment4 Interventions
In this study we will be administering from 1 x 10\^6 to 1 x 10\^9 transduced autologous VZV-specific CTLs, derived from VZV-specific memory T cells, so there will be no risk of alloreactivity. 6.1.1 Pre-infusion lymphodepletion for dose levels 9-11: Patients will receive 3 daily doses of cyclophosphamide together with fludarabine to induce lymphopenia, finishing at least 24 hours before T cell infusion. Cyclophosphamide will be given at a dose of 500 mg/m2/day followed by Fludarabine 30 mg/m2/day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
2010
Completed Phase 4
~2320
Fludarabine
2012
Completed Phase 4
~1860

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,018 Previous Clinical Trials
6,031,403 Total Patients Enrolled
13 Trials studying Neuroblastoma
279 Patients Enrolled for Neuroblastoma
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,974 Total Patients Enrolled
205 Trials studying Neuroblastoma
53,669 Patients Enrolled for Neuroblastoma
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
111 Previous Clinical Trials
2,797 Total Patients Enrolled
11 Trials studying Neuroblastoma
237 Patients Enrolled for Neuroblastoma

Media Library

GD2 T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01953900 — Phase 1
Neuroblastoma Research Study Groups: GD2 T cells plus VZV vaccine
Neuroblastoma Clinical Trial 2023: GD2 T cells Highlights & Side Effects. Trial Name: NCT01953900 — Phase 1
GD2 T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01953900 — Phase 1
~2 spots leftby Sep 2025
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