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Virus Therapy

EBV-specific CTLs for Neuroblastoma (NESTLES Trial)

Phase 1

Waitlist Available

Led By Andras A Heczey, MD

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

High risk neuroblastoma with a history of persistent or relapsed disease, or after initial therapy

Patients must have serum creatinine less than 3 times upper limit of normal

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

NESTLES Trial Summary

This trial is testing a new way to fight neuroblastoma, a form of cancer, by combining two different types of cells that each attack the disease in different ways. The new cell is made by attaching an antibody that recognizes neuroblastoma cells to a type of cell that normally fights infectious mononucleosis. This new cell is given to patients with neuroblastoma that has returned and is not responding to other treatments.

Who is the study for?

This trial is for children with high-risk neuroblastoma who have relapsed or persistent disease after initial therapy. They must not require oxygen (>90% on room air), expect to live at least 12 weeks, and recovered from previous chemotherapy effects. No investigational agents or tumor vaccines should have been received in the last 6 weeks. Participants need normal blood counts, liver and kidney function, no severe heart/lung issues, a decent performance score (Karnofsky/Lansky >60%), and specific immune cells from a prior study.Check my eligibility

What is being tested?

The trial tests modified immune cells (CTLs) that are trained to fight both neuroblastoma cancer cells and EBV virus by using an antibody called 14g2a attached to them. These 'chimeric receptor-T cells' aim to last longer in the body and effectively target cancer cells. Patients may receive an additional dose of these CTLs if their cancer has returned.See study design

What are the potential side effects?

Potential side effects include reactions related to the infusion of T-cells such as fever, chills, fatigue; allergic responses due to murine proteins; possible organ inflammation where T-cells gather; risk of infection increase due to immune system modification.

NESTLES Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My neuroblastoma is high risk and has either come back or didn't fully respond to initial treatment.

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My kidney function, measured by creatinine, is within normal limits.

Select...

I can care for myself but may not be able to do active work or play.

Select...

My immune cells have been modified to fight my cancer effectively.

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My tumor is not located where it could block my airway if it grows.

NESTLES 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

Evaluate the safety of escalating doses of 14g2a.zeta chimeric receptor transduced autologous EBV specific cytotoxic T-lymphocytes (EBV-CTL) and 14g2a.zeta transduced autologous peripheral blood T-cells

Secondary outcome measures

Compare the differential survival of these infused cells in an additional 6 patients treated at dose level #1 without CD45 antibody mediated lymphodepletion, to patients previously treated at dose levels #2 and #3.

Determine anti-tumor effects of transduced peripheral blood T-cells and EBV specific CTLs in vivo.

Determine the differential survival and function of these two infused cell-types in vivo, in particular to determine if chimeric receptor transduced EBV-CTLs survive longer than transduced peripheral-blood T-cells.

NESTLES Trial Design

1Treatment groups

Experimental Treatment

Group I: EBV specific CTLs w/out lymphodepletionExperimental Treatment1 Intervention

Escalating doses of 14g2a.zeta chimeric receptor transduced autologous EBV specific cytotoxic T-lymphocytes (EBV-CTL) and 14g2a.zeta transduced autologous peripheral blood T-cells administered to patients with Neuroblastoma.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Center for Cell and Gene Therapy, Baylor College of MedicineOTHER

111 Previous Clinical Trials

2,798 Total Patients Enrolled

11 Trials studying Neuroblastoma

244 Patients Enrolled for Neuroblastoma

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,001,933 Total Patients Enrolled

13 Trials studying Neuroblastoma

286 Patients Enrolled for Neuroblastoma

Andras A Heczey, MDPrincipal InvestigatorBaylor College of Medicine

1 Previous Clinical Trials

1 Trials studying Neuroblastoma

Media Library

EBV Specific CTLs (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00085930 — Phase 1

Neuroblastoma Research Study Groups: EBV specific CTLs w/out lymphodepletion

Neuroblastoma Clinical Trial 2023: EBV Specific CTLs Highlights & Side Effects. Trial Name: NCT00085930 — Phase 1

EBV Specific CTLs (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00085930 — Phase 1

Frequently Asked Questions

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

What potential perils are posed by EBV specific CTLs for individuals?

"Due to the minimal data supporting safety and efficacy, our team has assigned EBV specific CTLs a score of 1."

Answered by AI

Are there any spots still available for prospective participants of this trial?

"According to clinicaltrials.gov, there are no openings in this trial at the moment - it was first posted on April 1st 2003 and last updated on February 2nd 2022. However, 161 other studies are actively searching for participants right now."

Answered by AI

Recent research and studies

BloodJournal

Antitumor Activity and Long-term Fate of Chimeric Antigen Receptor–positive T Cells in Patients with Neuroblastoma

Louis, Chrystal U., Barbara Savoldo, Gianpietro Dotti, Martin Pule, Eric Yvon, G. Doug Myers, Claudia Rossig, et al.. 2011. “Antitumor Activity and Long-term Fate of Chimeric Antigen Receptor–positive T Cells in Patients with Neuroblastoma”. Blood. American Society of Hematology. doi:10.1182/blood-2011-05-354449.

clinicaltrials.govStudy

Blood T-Cells and EBV Specific CTLs Expressing GD-2 Specific Chimeric T Cell Receptors to Neuroblastoma Patients

Andras Heczey 2003. "Blood T-Cells and EBV Specific CTLs Expressing GD-2 Specific Chimeric T Cell Receptors to Neuroblastoma Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00085930.

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