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A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma

Phase II Trial of a Bivalent Vaccine With the Immunological Adjuvant OPT-821 (QS-21), in Combination With Oral β-glucan and Randomization of GM-CSF, for High-risk Neuroblastoma

NCT04936529•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of the study is to explore the combination of a bivalent vaccine, a sugar called beta-glucan (β-glucan), and a protein called granulocyte-macrophage colony stimulating factor (GM-CSF) as an effective treatment for people with high-risk neuroblastoma that is in complete remission. The combination may be effective because the different parts of the treatment work to strengthen the immune system's response against cancer cells in different ways.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Diagnosis of NB as defined by international criteria, 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,i.e., metastatic/non-localized disease with MYCN amplification (any age), MYCN-non-amplified metastatic disease \>18 months old, MYCNamplified 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.
•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.
•Hematologic Function
•* Absolute neutrophil count (ANC) ≥ 500/mcl
•* Absolute lymphocyte count ≥ 500/mcl
•* Hemaglobin (Hgb) ≥ 8 g/dL
•* Platelet count ≥ 50,000 mm\^3
•Renal Function o Serum creatinine ≤ 3.0 x ULN
+13 more criteria

Exclusion Criteria

•Patients w ith significant (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 (CTCAE v5.0)
•History of allergy to KLH, QS-21, OPT-821, or glucan.
•Active life-threatening infection requiring systemic therapy.
•Inability to comply with protocol requirements.
•Patients with history of allergy to GM-CSF or who are unable to obtain GM-CSF because of insurance issues are ineligible

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

August 2, 2021

Primary Completion Date

June 15, 2026

Completion Date

June 15, 2026

Last Updated

March 13, 2026

Enrollment

286

ESTIMATED participants

Conditions

Neuroblastoma

Interventions

β-glucan

DIETARY_SUPPLEMENT

GM-CSF

DRUG

OPT-821

BIOLOGICAL

Contacts

Brian Kushner, MD

CONTACT

1-833-675-5437 kushnerb@mskcc.org

Fiorella Iglesias Cardenas, MD, MS

CONTACT

1-833-675-5437

Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors

NCT06541262

NeuroblastomaEwing Sarcoma+3 more

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RECRUITINGPHASE1/PHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma

Inclusion Criteria

Exclusion Criteria

Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors

Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors

Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow

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