Status:
RECRUITING
GD2 Specific CAR and Interleukin-15 Expressing Autologous NKT Cells to Treat Children With Neuroblastoma
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Center for Cell and Gene Therapy, Baylor College of Medicine
Conditions:
Neuroblastoma
Eligibility:
All Genders
1-21 years
Phase:
PHASE1
Brief Summary
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 pos...
Detailed Description
In this study the first step is to collect blood from the patient to make the GINAKIT cells. Once the GINAKIT cells are made they will be administered to the patient. Patients will be treated on a si...
Eligibility Criteria
Inclusion
- 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 eligibility criteria).
- Weight greater than 12kg
- Negative QuantiFERON-TB or T-SPOT testing within 3 months prior to procurement
- Procurement
Exclusion
- 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 eligibility criteria and expected to tolerate lymphodepletion).
- 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
Key Trial Info
Start Date :
January 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 10 2040
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03294954
Start Date
January 18 2018
End Date
August 10 2040
Last Update
September 19 2025
Active Locations (1)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030