RecruitingPhase 1NCT03721068

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

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

Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

18 participants

Start Date

Feb 19, 2019

Study Type

INTERVENTIONAL

Conditions

Osteosarcoma Neuroblastoma

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.

Eligibility

Min Age: 18 Months

Plain Language Summary

Simplified for easier understanding

This trial is testing a new cell therapy called iC9.GD2.CAR.IL-15 — where a patient's own immune T cells are genetically engineered to target a protein called GD2 found on neuroblastoma (a childhood cancer) and osteosarcoma (a bone cancer) cells — in children and young adults whose cancer has relapsed or stopped responding to other treatments. **You may be eligible if...** - You have been diagnosed with high-risk neuroblastoma or osteosarcoma that has relapsed or not responded to standard treatment - Your cancer was originally confirmed by tissue biopsy or bone marrow sample - You are in acceptable overall health (Lansky or Karnofsky score of 60 or above) - Your life expectancy is at least 12 weeks - Your guardians have signed consent (HIPAA authorization) **You may NOT be eligible if...** - Your cancer does not express the GD2 protein at adequate levels - Your blood counts or organ function do not meet minimum requirements - You have active, uncontrolled brain tumors or spinal fluid involvement - You are pregnant or breastfeeding - You have had a prior allogeneic (donor) stem cell transplant or another CAR T-cell therapy Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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