Phase I Study of Umbilical Cord Blood Natural Killer (NK) Cell Therapy for Children With High-risk, R/R Neuroblastoma.

Sponsor
Sun Yat-sen University
Study ID
NCT06631391
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Day - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • umbilical cord blood NK cells — BIOLOGICAL
    This is a phase I prospective clinical trial, including phase Ia and phase Ib. Phase Ia include 3 dose levels, utilizing a 3+3 design principle, and each dose level will enroll at least 3 subjects. The recommended dose for phase Ia was used in phase Ib. Each patient receives two courses of umbilical cord blood NK cell therapy (a total of 8 infusions of umbilical cord blood NK cells) and other therapy.

Study Details

Neuroblastoma is the most common extracranial solid tumor, with more than half of the patients diagnosed at the metastatic stage, classified as high-risk. High-risk neuroblastoma has a poor prognosis and low survival rate. Despite treatment with induction, consolidation, and maintenance therapy including GD2 monoclonal antibody, the survival rate is only about 60%, and many patients still relapse, progress, and die. NK cell therapy is an emerging immunotherapy that can effectively inhibit and kill tumor cells without significant adverse reactions, reducing the risk of tumor recurrence and metastasis, and improving patients' immunity and quality of life. Its safety has been widely recognized. Currently, clinical trials of NK cell infusion therapy for neuroblastoma patients are ongoing, and NK cell-based immunotherapy holds great clinical promise for neuroblastoma. We plan to conduct a phase I clinical trial on umbilical cord blood NK cell therapy in combination with other treatments (GD2 antibody, chemotherpay, etc) for high-risk, recurrent/refractory neuroblastoma in children to determine the maximum tolerated dose of umbilical cord blood NK cell therapy in these patients, thereby laying the foundation for future combination therapies and phase II and III clinical studies.

Key Dates

First listed
Oct 8, 2024
Start date
Nov 1, 2024
Status verified
Feb 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment with umbilical cord blood NK cells
    All subjects will receive Ex vivo Expanded and activated umbilical cord blood NK cells infusion.

Primary Outcome Measure

To evaluate the safety and tolerability of umbilical cord blood natural killer cell injection in combination with other treatments of high-risk, recurrent/refractory neuroblastoma in children [ Time Frame: One weeks after the first cycle (each cycle is 28 days) ]

Central Contacts

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