GD2 Specific CAR and Interleukin-15 Expressing Autologous NKT Cells to Treat Children With Neuroblastoma

This study is testing a new approach for children with neuroblastoma that has come back or is hard to treat. It uses special immune cells called GINAKIT cells, which are made from your own blood. These cells are designed to recognize and kill cancer cells. The study will look at different doses of GINAKIT cells, both alone and in combination with another medicine called Etanercept. The main goal is to find the highest safe dose of GINAKIT cells when given with Etanercept. You may be able to join if you are between 1 and 21 years old and have neuroblastoma that meets certain criteria.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 70 participants to test different dose levels of GINAKIT cells, alone or with Etanercept.
What's involved
First, blood will be collected to create the GINAKIT cells. Before receiving GINAKIT cells, you will get chemotherapy (cyclophosphamide and fludarabine) for 3 days, followed by weekly Etanercept injections under the skin for 5 doses. You will then receive GINAKIT cells through an IV.
Compensation
Not stated in the trial record.
Follow-up
The main safety outcome will be measured 28 days after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03294954

GD2 Specific CAR and Interleukin-15 Expressing Autologous NKT Cells to Treat Children With Neuroblastoma

Recruiting
PHASE1Ages 1–21InterventionalTreatment
Baylor College of Medicine
~70 participants
Updated 2025-09-19 on ClinicalTrials.gov
What's tested:GINAKIT CellsGINAKIT cells + Etanercept

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose of autologous NKTs expressing a 2nd generation GD2-specific chimeric antigen receptor administered to patients with relapsed or refractory neuroblastoma in combination with Etanercept.
Measured over 28 days
Neuroblastoma
1 sites across 1 states
Texas1
  • Gengwen Tian, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine

Opens a ready-to-send draft in your own email app — review before sending.

  • Maximum tolerated dose of autologous NKTs expressing a 2nd generation GD2-specific chimeric antigen receptor administered to patients with relapsed or refractory neuroblastoma in combination with Etanercept.28 days

    Defined as the highest dose level that will have at most a 33% chance of inducing the following NKT-cell-related dose limiting toxicities (DLTs) within 28 days after infusion of NKTs in combination with Etanercept.