A Clinical Trial on Autologous NK Cells Combined With GD2 Monoclonal Antibody in the Treatment of… (NCT06948994) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Clinical Trial on Autologous NK Cells Combined With GD2 Monoclonal Antibody in the Treatment of Children With Newly Diagnosed High-risk or Relapsed/Refractory Neuroblastoma
15 participantsStarted 2025-05-01
Plain-language summary
This is a prospective, single-arm, open, single-center clinical trial to evaluate the safety and efficacy of autologous NK cells combined with chemotherapy and GD2 monoclonal antibody in the treatment of newly diagnosed high-risk or relapsed/refractory neuroblastoma in children. Fifteen eligible subjects are planned to be included. The objective is to evaluate the safety and efficacy of autologous NK cells combined with GD2 monoclonal antibody in the treatment of children with newly diagnosed high-risk or relapsed/refractory neuroblastoma, which is expected to be safe and effective in improving PFS and DCR in children with refractory/recurrent neuroblastoma.
Who can participate
Age range1 Year – 18 Years
SexALL
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Inclusion criteria
✓. Age 1-18 years (including 18 years), gender not restricted;
✓. Diagnosed with high-risk neuroblastoma and meeting the following conditions: high-risk neuroblastoma has undergone standardized treatment including induction therapy and consolidation therapy according to COG, SIOPEN or the expert consensus CCCG-NB-2021, and has entered the maintenance stage; high-risk neuroblastoma has undergone induction therapy with COG chemotherapy combined with GD2 immunotherapy and has entered the maintenance stage; any recurrence of high-risk neuroblastoma after standardized treatment; or the disease is initially determined to be in a refractory state.
✓. If it is relapsed/refractory neuroblastoma, there must be at least one measurable lesion according to RECIST 1.1 criteria;
✓. Normal major organ function, that is, meeting the following standards:
Exclusion criteria
✕. Uncontrollable active infections, or expected to receive systemic anti-infection or immunosuppressive therapy during participation in this trial;
✕. Any toxic reactions caused by previous anti-tumor treatments have not recovered to grade 1 or below (CTCAE 5.0 version) (hair loss is not restricted);
What they're measuring
1
adverse event
Timeframe: during the treatment phase
2
serious adverse event
Timeframe: during the treatment phase
3
overall survival
Timeframe: 3 years
4
event-free survival
Timeframe: 3 years
Trial details
NCT IDNCT06948994
SponsorGuangzhou Women and Children's Medical Center