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

Plain-language summary

This study examines the sequential use of gene-engineered NK cells followed by GD2-targeted CAR-T cells in patients with osteosarcoma or neuroblastoma that persists after standard treatment or has relapsed. It is a Phase 1 study and is currently recruiting.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Recruiting

Sponsor

Baylor College of Medicine

Intervention

i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cells, i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cells, i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cells

Start date

7/15/2026

Estimated completion

4/1/2044

Countries

United States

Related genes

Locations

• Houston, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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).