OncoMatch/Clinical Trials/NCT03294954
GD2 Specific CAR and Interleukin-15 Expressing Autologous NKT Cells to Treat Children With Neuroblastoma
Is NCT03294954 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies GINAKIT cells + Etanercept for neuroblastoma.
Treatment: GINAKIT cells + Etanercept — 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. T cells, also called T lymphocytes, are special white blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. Investigators have found from previous research that they can put a new gene into T cells that will make them recognize cancer cells and kill them. In a previous clinical trial, investigators made artificial genes called a chimeric antigen receptors (CAR), from an antibody called 14g2a that recognizes GD2, a molecule found on almost all neuroblastoma cells (GD2-CAR). Investigators put these genes into the patients' own T cells and gave them back to patients that had neuroblastoma. NKT cells are another special subgroup of white blood cells that can specifically go into tumor tissue of neuroblastoma. Inside the tumor, there are other white blood cells called macrophages which help the cancer cells to grow and recover from injury. NKT cells can specifically kill these macrophages and slow the tumor growth. We will expand NKT cells and add GD2-specific chimeric antigen receptors to the cells. We think these cells might be better able to attack NB since they also work by destroying the macrophages that allows the tumor to grow. The chimeric antigen receptor will also contain a gene segment to make the NKT cells last longer. This gene segment is called CD28. In addition, to further improve the antitumor activity of the GINAKIT cells we added another gene expressing a molecule called Interleukin -15 (IL-15). The combination of these 3 components showed the most antitumor activity by CAR expressing NKT cells and improved these cells' survival in animal models. We also found that a medicine called ETANercept can slow down neuroblastoma growth, which might enhance the effects of the modified cells. In this part of our study, we aim to treat children with hard-to-treat neuroblastoma using these modified NKT cells along with ETANercept. Though ETANercept has been used to treat other diseases, such as rheumatoid arthritis in children, there is limited information about the safety, efficacy, and risk of ETANercept treatment in combination with cellular therapies. GD2-CAR expressing NKTs have not been tested in patients so far. The purpose of this study is to find the largest effective and safe dose of GD2-CAR NKT cells (GINAKIT cells), to evaluate their effect on the tumor and how long they can be detected in the patient's blood and what affect they have on the patient's neuroblastoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroblastoma
Biomarker criteria
Required: GD2 CAR expression ≥ 20% in autologous NKT cells (≥ 20%)
Patients must have autologous transduced NKTs with greater than or equal to 20% expression of GD2-specific CAR.
Prior therapy
Cannot have received: immunosuppressive drugs (corticosteroids, tacrolimus, cyclosporine)
Currently receiving immunosuppressive drugs such as corticosteroids, tacrolimus or cyclosporine
Cannot have received: cyclophosphamide (cyclophosphamide)
Exception: severe previous toxicity
Severe previous toxicity from cyclophosphamide or fludarabine based on the enrolling physician's assessment
Cannot have received: fludarabine (fludarabine)
Exception: severe previous toxicity
Severe previous toxicity from cyclophosphamide or fludarabine based on the enrolling physician's assessment
Cannot have received: investigational drugs
Currently receiving any investigational drugs
Lab requirements
Blood counts
ANC ≥ 500/µl, platelet count ≥ 20,000/µl (patients may be transfused to obtain platelet count ≥ 20,000/µl)
Kidney function
Creatinine < 1.5 times the upper limit of normal
Liver function
Serum AST less than 3 times the upper limit of normal; Total Bilirubin less than 1.5 times the upper limit of normal
Cardiac function
Cardiac function must be within normal limits if cardiomegaly on imaging
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. 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. Pulse Ox greater than or equal to 90% on room air. 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 weeks of starting protocol therapy that is within normal limits.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Texas Children's Hospital · Houston, Texas
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