Status:
NOT_YET_RECRUITING
NKG2D.Zeta-NK Cell Conditioning With C7R.GD2.CAR-T Cells for Patients With Relapsed or Refractory Osteosarcoma or Neuroblastoma
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Center for Cell and Gene Therapy, Baylor College of Medicine
Conditions:
Relapsed Neuroblastoma
Refractory Neuroblastoma
Eligibility:
All Genders
1-24 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to find the largest safe dose of i15.NKG2D.zeta-NK cells in combination with C7R.GD2.CAR-T cells, and additionally to evaluate how long they can be detected in patients' b...
Detailed Description
To make the T cells, the investigators will take patient's blood and stimulate it with growth factors that make T cells grow. Investigators will use a retrovirus to insert the GD2-targeting chimeric a...
Eligibility Criteria
Inclusion
- PROCUREMENT INCLUSION:
- Patients with Neuroblastoma that have persistent disease after standard treatment or have relapsed/refractory disease.
- Or
- Patients with Osteosarcoma that have persistent disease after standard treatment or have relapsed/refractory disease.
- Karnofsky/Lansky score of 60% or greater.
- Informed consent and assent (as applicable) obtained from parent/guardian and child.
- Greater than 1 year of age.
- PROCUREMENT EXCLUSION:
- History of hypersensitivity to murine protein-containing products.
- Known presence of Human Anti-Mouse Antibodies (HAMA).
- Active autoimmune disease (requiring immunosuppressive treatment in the past 6 months).
- Primary brain tumor or known brain metastases (on evaluation by MIBG and/or PET if applicable, CT/MRI/LP not required).
- TREATMENT INCLUSION:
- Patients with Neuroblastoma that have persistent disease after standard treatment or have relapsed/refractory disease.
- Or
- Patients with Osteosarcoma that have persistent disease after standard treatment or have relapsed/refractory disease.
- Karnofsky/Lansky score of 50% or greater
- Pulse Ox greater than or equal to 90% on room air
- AST less than 5 times upper limit of normal (less than 10 times upper normal if known with metastatic liver disease)
- Total bilirubin less than 3 times the upper limit of normal
- Serum creatinine less than 3 times upper limit of normal
- Available autologous T-cells with greater than or equal to 20% expressing GD2.CAR
- Informed consent and assent (as applicable) obtained from parent/guardian and child.
- Greater than 1 year of age.
- Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study.
- TREATMENT EXCLUSION:
- History of hypersensitivity to murine protein containing products (patients who have undergone desensitization and successful re-challenge without hypersensitivity reaction are eligible).
- Known presence of Human Anti-Mouse Antibodies (HAMA).
- Tumor potentially causing airway obstruction per investigator discretion.
- Pregnancy or lactation / will not use birth control methods.
- Currently receiving immunosuppressive drugs (patients on low dose corticosteroids are eligible: less than 0.25 mg/kg/day of prednisone/equivalent).
- Primary brain tumor or known brain metastases (on evaluation by MIBG and/or PET if applicable, CT/MRI/LP not required).
Exclusion
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2043
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT07211737
Start Date
November 1 2025
End Date
December 1 2043
Last Update
October 8 2025
Active Locations (1)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030