Approval Probability
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GD2-GD3 vaccine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| vaccine group one | EXPERIMENTAL | Patients will receive a total of 7 subcutaneous injections, at weeks 1, 2, 3, 8 , 20 , 32 , and 52. Minor schedule adjus tment s are permitted , as needed Vaccines must occur a inimum of 6 days apart. The last three vaccine s can be administered up to one week earlier or later than indicated without representing a protocol violation.Patients assigned to in Group 1 will receive o ral β glucan (40 mg/kg/day) starting at week 6 or 7 and continue with approximately 2 weeks on, 2 weeks off, up to 1 cycle after the last vaccination . |
| vaccine group two | EXPERIMENTAL | Patients will receive a total of 7 subcutaneous injections, at weeks 1, 2, 3, 8 , 20 , 32 , and 52. Minor schedule adjus tment s are permitted , as needed Vaccines must occur a minimum of 6 days apart. The last three vaccine s can be administered up to one week earlier or later than indicated without representing a protocol violation.Patients assigned to Group 2 will receive oral β glucan (40 mg/kg/day) starting week 1 and continue with approximately 2 weeks on, 2 weeks off, up to 1 cycle after the last vaccination . |
| vaccine group three | EXPERIMENTAL | Patients will receive a total of 7 subcutaneous injections, at weeks 1, 2, 3, 8 , 20 , 32 , and 52. Minor schedule adjus tment s are permitted , as needed Vaccines must occur a minimum of 6 days apart. The last three vaccine s can be administered up to one week earlier or later than indicated without representing a protocol violation.Group 3 will include patients who have previously received vaccine and oral β glucanglucan. Patients in this group will not be randomized using the MSK CRDB system. They will be treated as patients in Group 1 and receive o ral β glucan (40 mg/kg/day) starting at week 6 or 7 and continue with approximately 2 weeks on, 2 weeks off, up to 1 cycle after the last vaccination . They will not be eligible for primary endpoint. |
| Name | Type | Description |
|---|---|---|
| adjuvant OPT-821 in a vaccine containing two antigens (GD2L and GD3L) covalently linked to KLH | BIOLOGICAL | Pts receive a total of 7 subcutaneous injections, at weeks 1, 2, 3, 8, 20, 32, \& 52. Minor schedule adjustments are permitted, as needed. Vaccines must occur a minimum of 6 days apart. Induction of antibody response against the target antigens will be assessed. A fixed dose of oral β-glucan (40 mg/kg/day) is started at week 6 or 7(to allow time for generation of antibodies), \& continued as approximately 2 weeks on, 2 weeks off, up to 1 cycle after the last vaccination. Neutrophils will be tested for glucan effects on cytotoxicity. Antineuroblastoma activity will be monitored using standard radiographic \& bone marrow studies, as well as RT-PCR for measurement of minimal residual disease in blood \& bone marrow. Phase II treatment schema for patients in 1st CR/VGPR or \>2nd CR/VGPR will be the same for the vaccine as in phase I except OPT-821 will be given at a fixed dose of 150 mcg/m2. |
| oral β-glucan | BIOLOGICAL | Phase II Patients will be randomized to starting oral β-glucan (40 mg/kg/day) in week 1 or in week 6. |
Inclusion Criteria: * Diagnosis of neuroblastoma (NB) as defined by international criteria,\[104\] i.e., histopathology (confirmed by the MSKCC Department of Pathology) or bone marrow metastases plus high urine catecholamine levels. * High-risk NB as defined by risk-related treatment guidelines and...
The GD2-GD3 vaccine is being studied for high-risk neuroblastoma, a pediatric cancer of the sympathetic nervous system. It is given with escalating doses of the immunological adjuvant OPT-821 and in combination with oral beta-glucan. It is an investigational therapy and has not been approved for any indication.
The GD2-GD3 vaccine is being developed by Y-mAbs Therapeutics, Inc., which trades on the Nasdaq under the ticker YMAB. The company is the sponsor of the clinical program evaluating the vaccine in high-risk neuroblastoma.
The GD2-GD3 vaccine is in Phase 1 clinical development. It is an investigational vaccine and is not FDA approved. The Phase 1 study is listed as active but no longer recruiting participants.
The GD2-GD3 vaccine is being evaluated in the Phase 1 trial NCT00911560, titled Bivalent Vaccine With Escalating Doses of the Immunological Adjuvant OPT-821, in Combination With Oral beta-glucan for High-Risk Neuroblastoma. The trial is active but not recruiting, is controlled, and has enrolled 374 participants in the United States.
The GD2-GD3 vaccine contains two antigens, GD2L and GD3L, covalently linked to KLH, together with the immunological adjuvant OPT-821. It is administered with escalating doses of OPT-821 in combination with oral beta-glucan in the high-risk neuroblastoma study.