NKG2D.Zeta-NK and C7R.GD2.CAR-T Cells for Relapsed/Refractory Osteosarcoma or Neuroblastoma

This study is testing a new treatment for children and young adults (ages 1 to 24) with neuroblastoma or osteosarcoma that has come back or hasn't responded to other treatments. This treatment uses special immune cells called i15.NKG2D.zeta NK cells and C7R.GD2.CAR-T cells. These cells are designed to target a substance called GD2 found on the cancer cells. The main goal is to find the highest safe dose of these cells when given together. Researchers will also look at how long these cells stay in your body and what effect they have on your cancer. This is a gene transfer study, meaning new genes are added to your immune cells to help them fight the cancer.

Study design
This study plans to enroll 27 participants. It is designed to find the safest dose of the study treatments.
What's involved
You would have your blood taken to create the special T cells. You would receive an infusion of i15.NKG2D.zeta-NK cells, followed by C7R.GD2.CAR-T cells five days later. You will be monitored for about 3 hours after the NK cell infusion.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for a total of 15 years to monitor for any long-term side effects from the gene transfer.

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

NCT07211737

NKG2D.Zeta-NK Cell Conditioning With C7R.GD2.CAR-T Cells for Patients With Relapsed or Refractory Osteosarcoma or Neuroblastoma

Recruiting
PHASE1Ages 1–24InterventionalTreatment
Baylor College of Medicine
~27 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cells

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-limiting toxicity (DLT) rate
Measured over 4 weeks post-CAR-T cell infusion
+1 more outcome measured
Relapsed Neuroblastoma
Refractory Neuroblastoma
Relapsed Osteosarcoma
Refractory Osteosarcoma
1 sites across 1 states
Texas1
  • Leander D Timothy, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine
  • Shoba A Navai, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine
  • Stephanie L Fetzko, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine

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  • Dose-limiting toxicity (DLT) rate4 weeks post-CAR-T cell infusion

    Proportion of participants with DLTs related to the combination of NK cell and T cell infusions evaluated as per the NCI CTCAE v5.0 criteria

  • Maximum tolerated dose (MTD) of i15.NKG2D.zeta-NK cells when given in combination with C7R.GD2.CAR-T cells4 weeks post CAR-T infusion of the last participant

    The dose level of infused NK cells for which the DLT rate is approximately 0.3