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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

VEGAS Trial 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.Check my eligibility

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.See study design

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.

VEGAS Trial 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.

VEGAS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of patients with dose limiting toxicity

Secondary outcome measures

Amount of T cells in the blood after the infusions

Number of patients with a response to the T cells

VEGAS 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

1995

Completed Phase 3

~3780

Fludarabine

2012

Completed Phase 3

~1100

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,154 Total Patients Enrolled

13 Trials studying Neuroblastoma

279 Patients Enrolled for Neuroblastoma

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,127 Total Patients Enrolled

205 Trials studying Neuroblastoma

53,702 Patients Enrolled for Neuroblastoma

Center for Cell and Gene Therapy, Baylor College of MedicineOTHER

111 Previous Clinical Trials

2,791 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what illnesses can GD2 T cells be applied therapeutically?

"GD2 T cells are the primary line of treatment for multiple sclerosis. This immunotherapy is also beneficial in treating leukemia, myelocytic, acute, retinoblastoma and histiocytic lymphomas."

Answered by AI

What is the size of the cohort being monitored in this experiment?

"This experiment is no longer recruiting individuals. It was initially advertised on the 1st of April 2014 and last revised on the 11th of April 2022. Currently, there are 614 trials for neuroblastoma and 900 investigations into GD2 T cells that are looking to enroll patients."

Answered by AI

Is this research still recruiting participants?

"The research, first published in April 2014 and last modified on April 11th 2022, is not actively recruiting patients. However, there are a plethora of other clinical trials that require participants at the moment - 1514 to be exact."

Answered by AI

Have other experiments utilized GD2 T cells in the past?

"Currently, there are 900 active clinical trials involving GD2 T cells and 167 of them have reached the Phase 3 stage. Most studies for this particular therapeutic can be found in Philadelphia, Pennsylvania; however, many other medical centres across 29024 locations also offer these treatments."

Answered by AI