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RECRUITING
NCT03721068
PHASE1

Study of CAR T-Cells Targeting the GD2 With IL-15+iCaspase9 for Relapsed/Refractory Neuroblastoma or Relapsed/Refractory Osteosarcoma

Sponsor: UNC Lineberger Comprehensive Cancer Center

View on ClinicalTrials.gov

Summary

The body has different ways of fighting infections and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells. Antibodies are molecules that fight infections and protect your body from diseases caused by bacteria and toxic substances. Antibodies work by sticking to those bacteria or substances, which stops them from growing and causing bad effects. T cells are special infection-fighting blood cells that can kill other cells, including tumor cells or cells that are infected. Both antibodies and T cells have been used to treat patients with cancers. They both have shown promise, but neither alone has been enough to cure most patients. This multicenter study is designed to combine both T cells and antibodies in order to create a more effective treatment. The treatment that is being researched is called autologous T lymphocyte chimeric antigen receptor cells (CAR) cells targeted against the disialoganglioside (GD2) antigen that express Interleukin (IL)-15, and the inducible caspase 9 safety switch (iC9), also known as iC9.GD2.CAR.IL-15 T cells.

Official title: A Phase I Study of Autologous Activated T-Cells Expressing a 2nd Generation GD2 Chimeric Antigen Receptor, IL-15, and iCaspase9 Safety Switch Administered To Patients With Relapsed/Refractory Neuroblastoma or Relapsed/Refractory Osteosarcoma

Key Details

Gender

All

Age Range

18 Months - Any

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2019-02-19

Completion Date

2044-06-19

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

BIOLOGICAL

iC9.GD2.CAR.IL-15 T-cells

Three dose levels are being evaluated: 0.5 x 10\^6, 1.0 x 10\^6, 1.5 x 10\^6

DRUG

Cyclophosphamide

500 mg/m\^2 IV dose on days 1-2 for lymphodepletion prior to cell infusion

DRUG

Fludarabine

30 mg/m\^2 IV dose on days 1-4 for lymphodepletion prior to cell infusion

Locations (2)

Emory - Winship Cancer Institute

Atlanta, Georgia, United States

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States