Table 1.
Currently active clinical trials for neuroblastoma immunotherapy.
| Anti-GD2 immunotherapy | ||||
|---|---|---|---|---|
| Approach | Agent combination | Phase | NCT identifier | Start year |
| Naked antibody (murine 3F8) | 3F8, allogeneic NK cells, cyclophosphamide, vincristine, topotecan | I | NCT00877110 ∗ | 2009 |
| 3F8, GM-CSF, isotretinoin | II | NCT01183897 ∗, NCT01183884∗ | 2010 | |
| N/A | NCT02100930 | 2014 | ||
|
| ||||
| Naked antibody (chimeric dinutuximab) | Dinutuximab, irinotecan, temozolomide | II | NCT01767194 ∗ | 2013 |
| Dinutuximab, autologous NK cells, lenalidomide | I | NCT02573896 | 2015 | |
| Dinutuximab, 131I-metaiodobenzylguanidine | I | NCT03332667 | 2017 | |
|
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| Naked antibody (chimeric dinutuximab-beta, produced in CHO) | Dinutuximab-beta, IL-2, isotretinoin | III | NCT01704716 | 2012 |
| Dinutuximab-beta | II | NCT02743429 | 2016 | |
| Dinutuximab-beta, nivolumab | I | NCT02914405 | 2016 | |
| Dinutuximab-beta, haploidentical NK cells, IL-2, cyclophosphamide | I/II | NCT03242603 | 2017 | |
|
| ||||
| Naked antibody (humanized hu3F8) | hu3F8 | I | NCT01419834 | 2011 |
| hu3F8, GM-CSF | I/II | NCT01757626 ∗ | 2012 | |
| III | NCT03363373 | 2017 | ||
| hu3F8, IL-2 | I | NCT01662804 ∗ | 2012 | |
| hu3F8, haploidentical NK cells, IL-2, cyclophosphamide | I | NCT02650648 | 2016 | |
| hu3F8, GM-CSF, isotretinoin | II | NCT03033303 | 2017 | |
| hu3F8, irinotecan, temozolomide, GM-CSF | Pilot | NCT03189706 | 2017 | |
|
| ||||
| Naked antibody (humanized hu14.18) | hu14.18K322A, allogeneic NK cells, IL-2, GM-CSF, combination chemotherapy | I | NCT01576692 ∗ | 2012 |
| hu14.18K322A, allogeneic NK cells, IL-2, G-CSF, GM-CSF, combination chemotherapy | II | NCT01857934 | 2013 | |
|
| ||||
| Immunocytokine | hu14.18-IL2, haploidentical NK cells | I | NCT03209869 | 2017 |
|
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| Radioimmunoconjugate | 131I-3F8 | II | NCT00445965 ∗ | 2007 |
|
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| T cell engaging bispecific antibody | hu3F8-scBA, activated T cells, GM-CSF, IL-2 | I/II | NCT02173093 | 2014 |
|
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| Adoptive NK cell transfer | HLA-haploidentical HCT, allogeneic NK cells | II | NCT02100891 | 2014 |
|
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| Adoptive NKT cell transfer | Autologous anti-GD2 NKT cells expressing IL-15, cyclophosphamide, fludarabine | I | NCT03294954 | 2017 |
|
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| Adoptive T cell transfer | Autologous anti-GD2 3rd-gen iC9 CAR-modified T cells, pembrolizumab, cyclophosphamide, fludarabine | I | NCT01822652 ∗ | 2013 |
| Autologous anti-GD2 4th-gen iC9 CAR-modified T cells | II | NCT02765243 | 2016 | |
| Autologous anti-GD2 2nd-gen CAR-modified T cells, cyclophosphamide, fludarabine | I | NCT02761915 | 2016 | |
| Autologous anti-GD2 iC9 CAR-modified T cells | I/II | NCT03373097 | 2017 | |
|
| ||||
| Vaccine | Gene-modified SJNB-JF-IL2 and SJNB-JF-LTN in conjunction with unmodified SKNLP (neuroblastoma cell vaccine) | I/II | NCT00703222 ∗ | 2008 |
| Bivalent GD2/GD3 lactone vaccine with OPT-821 adjuvant, oral β-glucan | I/II | NCT00911560 | 2009 | |
| Gene-modified SJNB-JF-IL2 and SJNB-JF-LTN in conjunction with unmodified SKNLP (neuroblastoma cell vaccine), oral cyclophosphamide | I/II | NCT01192555 ∗ | 2010 | |
|
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| Anti-CD171 immunotherapy | ||||
|
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| Adoptive T cell transfer | Autologous anti-CD171 CAR-modified T cells (2nd- and 3rd-gen) expressing EGFRt | I | NCT02311621 | 2014 |
|
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| Anti-NGcGM3 immunotherapy | ||||
|
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| Naked antibody (anti-idiotype vaccine, murine) | Racotumomab | II | NCT02998983 | 2016 |
|
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| Anti-B7-H3 immunotherapy | ||||
|
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| Radioimmunotherapy (murine 131I-8H9) | 131I-conjugated omburtomab | I | NCT00089245 | 2004 |
| 131I-conjugated omburtomab | II/III | NCT03275402 | 2017 | |
|
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| Anti-NY-ESO-1 immunotherapy | ||||
|
| ||||
| Adoptive T cell transfer | Autologous anti-NY-ESO-1 CAR-modified T cells | I | NCT02457650 | 2015 |
∗Active, not recruiting (from http://clinicaltrials.gov). CAR: chimeric antigen receptor; EGFRt: truncated epidermal growth factor receptor; HCT: hematopoietic cell transplantation; HLA: human leukocyte antigen; hu3F8-scBA: anti-GD2/anti-CD3 (hu3F8): single chain bispecific antibody; iC9: inducible caspase 9 suicide gene.