Recruiting
Phase 2

Vaccine & Beta-glucan

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06057948

Conditions

Neuroblastoma

High-risk Neuroblastoma

Metastatic Neuroblastoma

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

OPT-821 (QS-21)

oral β-glucan

Study Details

Brief summary:

The purpose of this study is to test which treatment schedule of β-glucan with bivalent vaccine is more effective for participants with high-risk neuroblastoma that is in complete remission.

Conditions

Neuroblastoma

High-risk Neuroblastoma

Metastatic Neuroblastoma

Study ID

NCT06057948

Start date

Sep 21, 2023

Status verified date

Jul, 2026

Completion date

Mar 21, 2027

Anticipated

Primary completion date

Mar 21, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

94 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1

Participants will receive oral β-glucan (40 mg/kg/day) for 14 days on, and 14 days off, beginning with vaccination #1 and continuing until vaccination #5 (\~20 weeks), then only one 14-day cycle with each of vaccinations #6-#10.

experimental: Group 2

Participants will receive oral β-glucan (40 mg/kg/day) for 14 days on, and 14 days off, beginning with vaccination #1 and continuing until vaccination #7 (\~52 weeks), then only one 14-day cycle with each of vaccinations #8-#10.

Interventions

OPT-821 (QS-21)

Comprised of the immunological adjuvant OPT-821 (QS-21)

oral β-glucan

Participants will be randomized to receive this agent in two different schedules

Primary outcome measure

  • Mean antibody titer in ng/ml of anti-GD2 IgG1 titer [ Time Frame: up to 32 weeks ]

Central Contacts and Locations

Central contacts

Brian Kushner, MD

1-833-MSK-KIDSkushnerb@MSKCC.ORG

Fiorella Iglasias Cardenas, MD, MS

1-833-MSK-KIDSiglesiaf@mskcc.org

Locations

Memorial Sloan Kettering at Basking Ridge (Consent only)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Brian Kushner, MD

833-675-5491

Memorial Sloan Kettering Monmouth (Consent Only)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Brian Kushner, MD

833-675-5491

Memorial Sloan Kettering Bergen (Consent Only)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Brian Kushner, MD

833-675-5491

Memorial Sloan Kettering Suffolk-Commack (Consent only)

Recruiting

Commack, New York, United States, 11725

Contacts

Brian Kushner, MD

833-675-5491

Memorial Sloan Kettering Westchester (Consent only)

Recruiting

Harrison, New York, United States, 10604

Contacts

Brian Kushner, MD

833-675-5491

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Brian Kushner, MD

833-675-5491

Memorial Sloan Kettering Nassau (Consent Only)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Brian Kushner, MD

833-675-5491

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Keywords

  • Neuroblastoma
  • High-risk Neuroblastoma
  • Metastatic Neuroblastoma
  • HR-NB
  • Memorial Sloan Kettering Cancer Center
  • 23-198

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-07-28.