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New treatment option for Neuroblastoma
Official title Study of CAR T-Cells Targeting the GD2 With IL-15+iCaspase9 for Relapsed/Refractory Neuroblastoma or Relapsed/Refractory Osteosarcoma
ClinicalTrials.gov ID: NCT03721068
What this study is testing
What is iC9.GD2.CAR.IL-15 T-cells?
iC9.GD2.CAR.IL-15 T-cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neuroblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The body has different ways of fighting infections and disease. No single way seems perfect for fighting cancer.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- All clinical and laboratory data required for determining eligibility must be available in the subject's medical/research record which will serve as...
- Written HIPAA authorization signed by legal guardian.
- Adequate performance status as defined by Lansky or Karnofsky performance status of ≥ 60 (Lansky for \<16 years of age).
- Life expectancy ≥12 weeks.
- Histological confirmation of neuroblastoma or ganglioneuroblastoma at initial diagnosis. Bone marrow samples are acceptable as confirmation of...
You likely can't join if
- for the Study people meeting any of the following exclusion criteria will not be able to participate in this study (procurement, lymphodepletion, and...
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Has a known additional malignancy that is active and/or progressive requiring treatment.
- History of hypersensitivity reactions to murine protein-containing products.
- History of hypersensitivity to cyclophosphamide or fludarabine.
See the full eligibility criteria
- All clinical and laboratory data required for determining eligibility must be available in the subject's medical/research record which will serve as the source document. Because of the nature of iC9.GD2.CAR.IL-15 T cell...
- Written HIPAA authorization signed by legal guardian.
- Adequate performance status as defined by Lansky or Karnofsky performance status of ≥ 60 (Lansky for \<16 years of age).
- Life expectancy ≥12 weeks.
- Histological confirmation of neuroblastoma or ganglioneuroblastoma at initial diagnosis. Bone marrow samples are acceptable as confirmation of neuroblastoma, confirmation of osteosarcoma at diagnosis
- High-risk neuroblastoma with persistent/refractory or relapsed disease, defined as:
- First or greater relapse of neuroblastoma following completion of aggressive multi-drug frontline therapy.
- First episode of progressive neuroblastoma during aggressive multi-drug frontline therapy. Persistent/refractory neuroblastoma as defined by less than a complete response by the revised International Neuroblastoma...
- Patients must be diagnosed with high risk neuroblastoma at initial diagnosis or if non-high risk at time of initial diagnosis must have had evidence of metastatic progression when \>18 months of age as defined in the...
- Measurable or evaluable disease per Revised INRC for people with neuroblastoma or measurable disease by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 criteria for people with osteosarcoma.
- Adequate central nervous system function as defined by:
- No known Central Nervous System ( CNS) disease
- No seizure disorder requiring antiepileptic drug therapy
- for the Study people meeting any of the following exclusion criteria will not be able to participate in this study (procurement, lymphodepletion, and cell infusion).
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Has a known additional malignancy that is active and/or progressive requiring treatment.
- History of hypersensitivity reactions to murine protein-containing products.
- History of hypersensitivity to cyclophosphamide or fludarabine.
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Chapel Hill, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 months and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Chapel Hill, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.