NKG2D.zeta-NK cells plus C7R.GD2.CAR-T cells for relapsed or refractory neuroblastoma or osteosarcoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human trial aims to find the largest safe dose of i15.NKG2D.zeta-NK cells given with C7R.GD2.CAR-T cells in patients whose neuroblastoma or osteosarcoma expresses GD2. Patients receive both cell therapies without prior lymphodepletion, with infusion timing coordinated around Day -5 and close monitoring for several hours post-infusion. The study also tracks how long the cells persist in blood and their potential effects on the cancer, with long-term follow-up planned for up to 15 years for safety signals related to gene transfer. Participants are monitored for adverse events and response as part of an early-phase, dose-escalation framework. Primary goals include safety and determination of a recommended dose for future studies.

Why it matters

Who can join: the full rules

PROCUREMENT INCLUSION:

1. 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.
2. Karnofsky/Lansky score of 60% or greater.
3. Informed consent and assent (as applicable) obtained from parent/guardian and child.
4. Greater than 1 year of age.

PROCUREMENT EXCLUSION:

1. History of hypersensitivity to murine protein-containing products.
2. Known presence of Human Anti-Mouse Antibodies (HAMA).
3. Active autoimmune disease (requiring immunosuppressive treatment in the past 6 months).
4. Primary brain tumor or known brain metastases (on evaluation by MIBG and/or PET if applicable, CT/MRI/LP not required).

TREATMENT INCLUSION:

1. 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.
2. Karnofsky/Lansky score of 50% or greater
3. Pulse Ox greater than or equal to 90% on room air
4. AST less than 5 times upper limit of normal (less than 10 times upper normal if known with metastatic liver disease)
5. Total bilirubin less than 3 times the upper limit of normal
6. Serum creatinine less than 3 times upper limit of normal
7. Available autologous T-cells with greater than or equal to 20% expressing GD2.CAR
8. Informed consent and assent (as applicable) obtained from parent/guardian and child.
9. Greater than 1 year of age.
10. Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study.

TREATMENT EXCLUSION:

1. History of hypersensitivity to murine protein containing products (patients who have undergone desensitization and successful re-challenge without hypersensitivity reaction are eligible).
2. Known presence of Human Anti-Mouse Antibodies (HAMA).
3. Tumor potentially causing airway obstruction per investigator discretion.
4. Pregnancy or lactation / will not use birth control methods.
5. Currently receiving immunosuppressive drugs (patients on low dose corticosteroids are eligible: less than 0.25 mg/kg/day of prednisone/equivalent).
6. Primary brain tumor or known brain metastases (on evaluation by MIBG and/or PET if applicable, CT/MRI/LP not required).

Where it's running

• Texas Children's Hospital
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Leander D Timothy, MD — Baylor College of Medicine
• Study coordinator: Robin Parihar, MD, PhD
• Email: rxpariha@texaschildrens.org
• Phone: 832-824-4746

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.