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New treatment option for Relapsed Neuroblastoma
Official title NKG2D.Zeta-NK Cell Conditioning With C7R.GD2.CAR-T Cells for Patients With Relapsed or Refractory Osteosarcoma or Neuroblastoma
ClinicalTrials.gov ID: NCT07211737
What this study is testing
What is i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cells?
i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed neuroblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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' blood and what affect they have on patients' cancer. Patients eligible for this study have neuroblastoma or osteosarcoma that expresses a substance on the cancer cells called GD2.
- Phase 1: an early, usually small safety study
- Time commitment: about 4 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 24
You may be able to join if
- PROCUREMENT INCLUSION:
- Patients with Neuroblastoma that have persistent disease after standard treatment or have relapsed/refractory disease. Or Patients with Osteosarcoma...
- 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:
See the full eligibility criteria
- 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...
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 24 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.