NCT06057948 A Study of a Vaccine in Combination With Beta-glucan in People With Neuroblastoma
| NCT ID | NCT06057948 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Neuroblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 94 participants |
| Start Date | 2023-09-21 |
| Primary Completion | 2027-03-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 94 participants in total. It began in 2023-09-21 with a primary completion date of 2027-03-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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. * 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.
Contact & Investigator
Brian Kushner, MD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT06057948 clinical trial?
This trial is open to participants of all sexes, studying Neuroblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06057948 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06057948 currently recruiting?
Yes, NCT06057948 is actively recruiting participants. Contact the research team at kushnerb@MSKCC.ORG for enrollment information.
Where is the NCT06057948 trial being conducted?
This trial is being conducted at Basking Ridge, United States, Middletown, United States, Montvale, United States, Commack, United States and 3 additional locations.
Who is sponsoring the NCT06057948 clinical trial?
NCT06057948 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Brian Kushner, MD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 94 participants.