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SUSPENDED
NCT04539366
PHASE1

Testing a New Immune Cell Therapy, GD2-Targeted Modified T-cells (GD2CART), in Children, Adolescents, and Young Adults With Relapsed/Refractory Osteosarcoma and Neuroblastoma, The GD2-CAR PERSIST Trial

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This phase I trial investigates the side effects and determines the best dose of an immune cell therapy called GD2CART, as well as how well it works in treating patients with osteosarcoma or neuroblastoma that has come back (relapsed) or does not respond to treatment (refractory). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this trial will come from the patient and will have a new gene put in them that makes them able to recognize GD2, a protein on the surface of tumor cells. These GD2-specific T cells may help the body's immune system identify and kill GD2 positive tumor cells.

Official title: GD2-CAR PERSIST: Production and Engineering of GD2-Targeted, Receptor Modified T Cells (GD2CART) for Osteosarcoma or Neuroblastoma to Increase Systemic Tumor Exposure

Key Details

Gender

All

Age Range

Any - 40 Years

Study Type

INTERVENTIONAL

Enrollment

67

Start Date

2022-01-25

Completion Date

2040-12-31

Last Updated

2026-05-04

Healthy Volunteers

No

Interventions

PROCEDURE

Biopsy Procedure

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo collection of blood

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

DRUG

Cyclophosphamide

Given IV

PROCEDURE

Echocardiography Test

Undergo ECHO

DRUG

Fludarabine Phosphate

Given IV

BIOLOGICAL

GD2-CAR-expressing Autologous T-lymphocytes

Given IV

PROCEDURE

Imaging Procedure

Undergo standard imaging scans

PROCEDURE

Magnetic Resonance Imaging of the Heart

Undergo cardiac MRI

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

OTHER

Questionnaire Administration

Ancillary studies

Locations (6)

Children's Hospital Los Angeles

Los Angeles, California, United States

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States