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CAR T-cell Therapy

Immune Cell Therapy for Childhood Cancer

Phase 1

Recruiting

Led By Rosandra N Kaplan

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing an immune cell therapy to see if it is effective in treating patients with osteosarcoma or neuroblastoma.

Who is the study for?

This trial is for children, adolescents, and young adults with relapsed or treatment-resistant osteosarcoma or neuroblastoma. Participants must have a certain level of physical functioning, adequate blood counts and organ function, confirmed diagnosis with specific disease criteria, and no limit on prior treatments but must meet certain timeframes since last therapy. Pregnant individuals are excluded.

What is being tested?

The trial tests GD2CART immune cell therapy to see its side effects and optimal dose in treating patients whose cancer has returned or isn't responding to treatment. Patients' T cells are modified to target GD2 protein on tumor cells potentially helping the immune system kill these cancer cells.

What are the potential side effects?

Potential side effects include reactions related to the infusion of modified T-cells such as fever, fatigue, headache; risk of infection; possible damage to non-tumor cells that also carry the GD2 protein; allergic reactions; and other typical chemotherapy-related side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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

Best response to GD2CART cells

Feasibility of producing GD2-CAR-expressing autologous T-lymphocytes (GD2CART) cells

Incidence of adverse events (AEs)

Secondary study objectives

Capacity for rimiducid (AP1903) to reverse unacceptable toxicity related to GD2CART administration

Other study objectives

Biomarkers

GD2 expression

Persistence of GD2CART 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: Treatment (GD2 CAR T)Experimental Treatment12 Interventions

LYMPHODEPLETION CHEMOTHERAPY: Patients receive fludarabine phosphate IV daily on days -5 to -2 and cyclophosphamide IV daily on days -4 to -2. GD2CART: Patients receive GD2CART cells IV on day 0. Patients also undergo ECHO, MUGA or cardiac MRI scan during screening, blood sample collection throughout the trial, and tumor biopsies and bone marrow aspiration and biopsy as clinically indicated. In addition, patients undergo standard imaging scans throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Imaging Procedure

2003

N/A

~70

Bone Marrow Biopsy

2021

Completed Phase 3

~230