A Study of a Vaccine in Combination With Beta-glucan in People With Neuroblastoma

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• AgeNo minimum to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• Diagnosis of NB as defined by international criteria,102 i.e., histopathology (confirmed by the MSK Department of Pathology) or BM metastases plus high urine catecholamine levels, or positivity in MIBG scan.
• HR-NB as defined by risk-related treatment guidelines and international criteria,102 i.e., metastatic/non-localized disease with MYCN amplification (any age), metastatic disease >18 months old, MYCN-amplified localized disease (any age), or disease resistant to standard chemotherapy. For those patients with a positive site of disease that is poorly visualized on a scan, it can be per PI discretion to repeat the scan or proceed with enrollment without a recent scan.
• HR-NB (as defined above) and in 1) first CR at ≥ 6 months from initiation of immunotherapy using anti-GD2 antibody, or 2) second or subsequent CR (achieved after treatment for PD). CR is defined according to the International Neuroblastoma Response Criteria. Patients with positive MIBG scan but negative FDG-PET scan, and CR in BM, are eligible. For those patients with a positive MIBG scan, the negative FDG-PET scan can be per PI discretion to repeat within the 45 day window period prior to enrollment.
• Patients with grade 3 toxicities or less using the Common Toxicity Criteria (Version 5.0) developed by the National Cancer Institute of the USA (CTCAE v5.0) related to hematologic, cardiac, neurological, pulmonary, renal, hepatic or gastrointestinal function as determined by blood tests or physical exam. Plus:
• Absolute neutrophil count (ANC) ≥ 500/mcl
• Absolute lymphocyte count ≥ 500/mcl
• >21 and <180 days between completion of systemic therapy and 1st vaccination.
• A negative pregnancy test is required for patients with child-bearing capability
• Signed informed consent indicating awareness of the investigational nature of this program.

You cannot join if

• Patients with grade 4 hematologic, cardiac, neurological, pulmonary, renal, hepatic or gastrointestinal function as determined by blood tests or physical exam, using the Common Toxicity Criteria (Version 5.0) developed by the National Cancer Institute of the USA.
• History of allergy to KLH, QS-21, OPT-821, or glucan
• Prior treatment with this vaccine.
• Active life-threatening infection requiring systemic therapy.
• Inability to comply with protocol requirements.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

saponin-based immunoadjuvant OBI-821. A purified, natural saponin isolated from the soapbark tree Quillaja saponaria Molina with potential immunoadjuvant activity. When co-administered with a vaccine, OBI-821 may increase antibody and cytotoxic T-lymphocyte (CTL) responses against the vaccine's targeted antigen(s). NCI Drug Dictionary

beta-glucan. A polysaccharide isolated from the cell walls of bacteria, plants, and fungi with immunostimulant and antineoplastic activities. In a solubilized form, beta-glucan binds to a lectin site within complement receptor 3 (CR3) on leukocytes, priming the receptor to trigger cytotoxic degranulation of leukocytes when leukocyte CR3 binds to complement 3 (iC3b)-coated tumors. Thus, the attachment of beta-glucan to CR3 of circulating leukocytes simulates leukocytes to kill iC3b-coated tumor cells in the same way as they kill iC3b-coated yeast. NCI Drug Dictionary

Treatments listed in the registry

• OPT-821 (QS-21) (Biological): Comprised of the immunological adjuvant OPT-821 (QS-21)
• oral β-glucan (Dietary Supplement): Participants will be randomized to receive this agent in two different schedules

Non Randomized · Parallel · masking: None

Main goals

• Mean antibody titer in ng/ml of anti-GD2 IgG1 titer (up to 32 weeks)

Planned enrollment: 100 (estimated).

• Memorial Sloan Kettering at Basking Ridge (Consent only), Basking Ridge, New Jersey
• Memorial Sloan Kettering Monmouth (Consent Only), Middletown, New Jersey
• Memorial Sloan Kettering Bergen (Consent Only), Montvale, New Jersey
• Memorial Sloan Kettering Suffolk-Commack (Consent only), Commack, New York
• Memorial Sloan Kettering Westchester (Consent only), Harrison, New York
• Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York
• Memorial Sloan Kettering Nassau (Consent Only), Uniondale, New York

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT06057948
• NCI Drug Dictionary: C91726
• NCI Drug Dictionary: C2678

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 13, 2026. Public record; not medical advice.