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Also known as oral β-glucan
glucan · 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...
β-glucan is being studied as an oral immunomodulatory agent in combination with a bivalent vaccine for the treatment of high-risk neuroblastoma. It is currently in Phase 1 clinical development as an investigational therapy for this indication.
β-glucan is an oral immunomodulatory agent that is being evaluated for its ability to enhance the immune response when combined with a bivalent vaccine in patients with high-risk neuroblastoma. Its mechanism of action involves modulating the immune system to potentially improve anti-tumor activity.
β-glucan is being developed by Y-mAbs Therapeutics, Inc. (NASDAQ: YMAB), a biopharmaceutical company focused on developing antibody-based therapies for cancer. The company is conducting a Phase 1 clinical trial of oral β-glucan in combination with a vaccine for neuroblastoma.
β-glucan is in Phase 1 clinical development. It is an investigational agent being studied in an active, not recruiting clinical trial for high-risk neuroblastoma. It has not been approved by regulatory authorities and remains under clinical investigation.
β-glucan is being evaluated in a Phase 1 clinical trial with the identifier NCT00911560. This trial is studying a bivalent vaccine with escalating doses of the immunological adjuvant OPT-821, in combination with oral β-glucan for high-risk neuroblastoma. The trial is active but not recruiting participants.
Yes, β-glucan is also known as oral β-glucan. In clinical trials, it is administered orally as an immunomodulatory agent in combination with other therapies for the treatment of high-risk neuroblastoma.