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New treatment option for Neuroblastoma
Official title GD2 Specific CAR and Interleukin-15 Expressing Autologous NKT Cells to Treat Children With Neuroblastoma
ClinicalTrials.gov ID: NCT03294954
What this study is testing
What is GINAKIT Cells?
GINAKIT Cells is an investigational medicine, given as an injection under the skin, 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
- This research study combines two different ways of fighting cancer: antibodies and Natural Killer T cells (NKT). Antibodies are types of proteins that protect the body from infectious diseases and possibly 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 1 to 21
You may be able to join if
- Procurement
- Relapsed or refractory high risk neuroblastoma
- Life expectancy of at least 12 weeks
- Age greater than 1 year and less than 21 years old
- Karnofsky/Lansky score of 60% or greater
You likely can't join if
- Rapidly progressive disease
- History or hypersensitivity to murine protein-containing products
- Tumor causing airway obstruction
- Currently receiving immunosuppressive drugs such as corticosteroids, tacrolimus or cyclosporine
- Severe previous toxicity from cyclophosphamide or fludarabine based on the enrolling physician's assessment
- HIV infection
See the full eligibility criteria
- Procurement
- Relapsed or refractory high risk neuroblastoma
- Life expectancy of at least 12 weeks
- Age greater than 1 year and less than 21 years old
- Karnofsky/Lansky score of 60% or greater
- Absence of HAMA prior to enrollment (only in patients that have been previously treated with murine antibodies)
- Ability to tolerate leukocyte apheresis
- Informed consent and assent (as applicable) obtained from parent/guardian and child.
- Patients must have an ANC greater than or equal to 500/µl, platelet count greater than or equal to 20,000/µl. Patients may be transfused to obtain a platelet count greater than or equal to 20,000/µl.
- Pulse Ox greater than or equal to 90% on room air
- Serum AST less than 3 times the upper limit of normal
- Total Bilirubin less than 1.5 times the upper limit of normal
- Creatinine \< 1.5 times the upper limit of normal
- Recovered from the acute toxic effects of all prior chemotherapy based on the enrolling physician's assessment (if some effects of chemotherapy are expected to last long term, patient is eligible if meeting other...
- Weight greater than 12kg
- Negative QuantiFERON-TB or T-SPOT testing within 3 months prior to procurement Procurement
- Rapidly progressive disease
- History or hypersensitivity to murine protein-containing products
- Tumor causing airway obstruction
- Currently receiving immunosuppressive drugs such as corticosteroids, tacrolimus or cyclosporine
- Severe previous toxicity from cyclophosphamide or fludarabine based on the enrolling physician's assessment
- HIV infection
- History of hypersensitivity, anaphylaxis, and/or adverse event with Etanercept Treatment Inclusion Criteria:
- Relapsed or refractory high risk neuroblastoma
- Life expectancy of at least 12 weeks
- Age greater than 1 year and less than 21 years old
- Karnofsky/Lansky score of 60% or greater
- Patients must have an ANC greater than or equal to 500/µl, platelet count greater than or equal to 20,000/µl. Patients may be transfused to obtain a platelet count greater than or equal to 20,000/µl.
- Pulse Ox greater than or equal to 90% on room air
- Serum AST less than 3 times the upper limit of normal
- Total Bilirubin less than 1.5 times the upper limit of normal
- Creatinine \< 1.5 times the upper limit of normal
- Recovered from the acute toxic effects of all prior chemotherapy based on the enrolling physician's assessment (if some effects of chemotherapy are expected to last long term, patient is eligible if meeting other...
- Absence of human anti-mouse antibodies (HAMA) prior to enrollment for patients who have received prior therapy with murine antibodies
- Patients must have autologous transduced NKTs with greater than or equal to 20% expression of GD2-specific CAR.
- Informed consent and assent (as applicable) obtained from parent/guardian and child.
- Weight greater than 12kg
- Negative QuantiFERON-TB or T-SPOT testing within 3 months prior to the start of LD Treatment Exclusion Criteria:
- Rapidly progressive disease
- Currently receiving any investigational drugs
- History or hypersensitivity to murine protein-containing products
- Cardiomegaly or bilateral pulmonary infiltrates on chest radiograph or CT. However, patients with cardiomegaly on imaging may be enrolled if they have an assessment of cardiac function (i.e., ECHO or MUGA) within 3...
- Tumor potentially causing airway obstruction
- Pregnancy or lactation or not willing to use birth control
- Currently receiving immunosuppressive drugs such as corticosteroids, tacrolimus or cyclosporine
- Severe previous toxicity form cyclophosphamide or fludarabine based on the enrolling physician's assessment
- HIV infection
- History of hypersensitivity, anaphylaxis, and/or adverse event with Etanercept
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 1 year to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, 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.