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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

No Placebo-Only Group

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.

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.

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.

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.

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

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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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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