Actively Recruiting
Phase 2 Trial of a Bivalent Vaccine with OPT-821 and Oral Beta-glucan for Treating High-Risk Neuroblastoma in Remission
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-07-28
94
Participants Needed
7
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying which treatment schedule of oral beta-glucan combined with a bivalent vaccine containing OPT-821 QS-21 is more effective for people with high-risk neuroblastoma who are in complete remission. This phase 2 trial evaluates two different beta-glucan dosing schedules alongside the vaccine to understand their impact on immune response. Participants receive oral beta-glucan at 40 mgkgday in cycles of 14 days on and 14 days off, starting with vaccination 1. One group continues this cycle until vaccination 5 20 weeks and then has one 14-day cycle with each vaccination from 6 to 10. The other group continues the cycle until vaccination 7 52 weeks and then one 14-day cycle with each vaccination from 8 to 10. Both groups receive the vaccine OPT-821 QS-21 throughout the study. During the study, participants undergo vaccinations and receive oral beta-glucan according to their group schedule for up to about one year. Researchers measure the mean antibody level of anti-GD2 IgG1 up to 32 weeks to assess immune response. Participants are monitored for side effects and adherence to the treatment schedule. The study lasts until March 2027, with ongoing assessments to evaluate the vaccine and beta-glucan combinations in maintaining remission.
CONDITIONS
Brief Title
A Study of a Vaccine in Combination With Beta-glucan in People With Neuroblastoma
Research Team
B
Brian Kushner, MD
F
Fiorella Iglasias Cardenas, MD, MS
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