Study of CAR T-Cells for Neuroblastoma or Osteosarcoma
This study is testing a new way to fight relapsed (returned) or refractory (not responding to treatment) neuroblastoma or osteosarcoma. It uses special immune cells called T-cells that are modified in the lab to better recognize and kill cancer cells. These modified cells, called iC9.GD2.CAR.IL-15 T-cells, are given after you receive two chemotherapy drugs, cyclophosphamide and fludarabine, to prepare your body. The main goal is to see how safe these T-cells are and what side effects they might cause in children and young adults. We are looking for 18 participants aged 18 months and older for this study.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 18 participants.
- What's involved
- You will be assessed for eligibility before cell collection and again before starting treatment. You will receive cyclophosphamide and fludarabine before the T-cell infusion.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety and side effects will be measured at 4 weeks after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of CAR T-Cells Targeting the GD2 With IL-15+iCaspase9 for Relapsed/Refractory Neuroblastoma or Relapsed/Refractory Osteosarcoma
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- George Hucks, MD · PRINCIPAL_INVESTIGATOR · UNC Lineberger Comprehensive Cancer Center
Who to contact
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What this trial measures
- Number of participants with adverse events as a measure of safety and tolerability of iC9.GD2.CAR.IL-15 T cells administered to pediatric subjects with relapsed or refractory neuroblastoma or relapsed/refractory osteosarcoma4 weeks
Toxicity will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (AEs) (CTCAE, version 5.0), a descriptive terminology which can be utilized for AE reporting. A grading (severity) scale is provided for each AE term/symptom: Grade 1 (Mild; asymptomatic); Grade 2 (Moderate; minimal, local or noninvasive intervention indicated); Grade 3 (Severe or medically significant but not immediately life-threatening; hospitalization indicated; disabling); Grade 4 (Life-threatening consequences; urgent intervention indicated); Grade 5 (Death related to AE). Immune effector cell-associated neurotoxicity syndrome (ICANS) symptoms will be graded according to the criteria outlined in the protocol on a scale from 1 (mild) to 4 (critical). Cytokine release syndrome (CRS) will be graded according to criteria outlined in the protocol on a scale from 1 (mild) to grade 5 (death).