Actively Recruiting
Study of CAR T-Cells Targeting the GD2 With IL-15+iCaspase9 for Relapsed/Refractory Neuroblastoma or Relapsed/Refractory Osteosarcoma
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-03-27
18
Participants Needed
2
Research Sites
1321 weeks
Total Duration
On this page
Sponsors
U
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of CAR T-Cells Targeting the GD2 With IL-15+iCaspase9 for Relapsed/Refractory Neuroblastoma or Relapsed/Refractory Osteosarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Legal guardian has signed HIPAA authorization.
- Performance status score of 60 or higher on Lansky (if under 16 years) or Karnofsky scale.
- Life expectancy of at least 12 weeks.
- Histological or bone marrow confirmation of neuroblastoma, ganglioneuroblastoma, or osteosarcoma.
- High-risk neuroblastoma with persistent, refractory, or relapsed disease after aggressive multi-drug frontline therapy or progressive disease during therapy.
- Measurable or evaluable disease per relevant criteria (INRC for neuroblastoma, RECIST v1.1 for osteosarcoma).
- Adequate central nervous system function with no known CNS disease or seizure disorder requiring antiepileptic drugs.
You will not qualify if you...
- Pregnant or breastfeeding.
- Active or progressive additional malignancy requiring treatment.
- History of hypersensitivity to murine protein-containing products.
- History of hypersensitivity to cyclophosphamide or fludarabine.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Emory - Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Withdrawn
2
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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