Two types of immune cells for neuroblastoma or osteosarcoma that returned or resisted treatment
Tests combined NK cells and CAR-T cells in young people with neuroblastoma or osteosarcoma.
Key facts
- Who runs it
- Baylor College of Medicine
- Where
- Houston, United StatesSee the site
- Trial code
- Registry title
- NKG2D.Zeta-NK Cell Conditioning With C7R.GD2.CAR-T Cells for Patients With Relapsed or Refractory Osteosarcoma or Neuroblastoma
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 27 people, planned
- Started
- 15 Jul 2026
- Expected to end
- Apr 2044
- Type of study
- Interventional
- Treatments tested
- i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cells
- Record updated
- 21 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and young people with neuroblastoma or osteosarcoma that came back or did not respond to treatment. It tests NK cells together with CAR-T cells.
- Age
- Older than 1 year, up to 24 years
- Sex
- All sexes can join
- Disease stage
- Neuroblastoma or osteosarcoma that persists after standard treatment, has come back, or did not respond to treatment. The cancer cells must have GD2.
- Earlier treatment
- Must have recovered from the acute side effects of all earlier chemotherapy and investigational drugs.
- Biomarker or test result
- The cancer must express GD2. The patient's own T cells must be available, with at least 20% expressing GD2.CAR.
Main reasons for not taking part
- Allergic reaction to products containing mouse protein, or known human anti-mouse antibodies (HAMA)
- Active autoimmune disease needing immunosuppressive treatment in the past 6 months (for cell collection)
- Primary brain tumor or known brain metastases
- Pregnancy or breastfeeding, or not using birth control
- Currently taking immunosuppressive drugs (low-dose corticosteroids are allowed)
The registry criteria, word for word
Show all 25 criteriaShow less
Other 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 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)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 24 years old?
Where in United States
- Texas Children's HospitalHouston, United StatesContact: Robin Parihar, MDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
Patients eligible for this study have neuroblastoma or osteosarcoma that expresses a substance on the cancer cells called GD2. This cancer has either come back after treatment or did not respond to the standard or other investigational treatments or therapies used to treat it. There is no standard treatment for these types of advanced cancers at this time. This is a gene transfer research study using special immune cells called NK cells and T cells. NK cells and T cells are types of white blood cell that help the body fight infection.
The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: NK cells and T cells. T cells are special infection-fighting blood cells that can kill cells infected with viruses and tumor cells. NK cells, another kind of infection-fighting cell, can recognize a wide range of cells in distress, including tumor cells and cells that help protect tumor cells in the cancer environment. Both NK cells and T cells have been used individually to treat patients with cancers. They have shown promise, but have not been strong enough individually to cure most patients.
Investigators have found from previous research that we can put a new gene into T cells that will make them recognize GD2, a substance found on almost all neuroblastoma and osteosarcoma cells. We can also put a new gene into NK cells that help them fight the tumor environment. Investigators know that T cells and NK cells need substances called cytokines to survive but the cells do not get enough cytokines after infusion into the body; therefore, the investigators have added the genes C7R and IL15 into the T and NK cells, respectively, to give each cell a constant supply of cytokine that helps them to survive longer.
The C7R.GD2.CAR-T cells and i15.NKG2D.zeta-NK cells are investigational products not approved by the Food and Drug Administration.
The group in the trial
- i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cellsTreatment being tested
Three dose levels will be evaluated. This is a dose escalating trial which will infuse doses of i15.NKG2D.zeta NK cells followed by a fixed dose of C7R.GD2.CAR T cells 5 days later.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- (INCITE-ON) Phase I Study of i15.NKG2D.Zeta-NK Cell Conditioning in the Tumor Micro-environment in Combination With C7R.GD2.CAR-T for the Treatment of Patients With Relapsed or Refractory Osteosarcoma or Neuroblastoma
- Plain-language title
- Two types of immune cells for neuroblastoma or osteosarcoma that returned or resisted treatmentGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07211737, who can take part
- Record updated
- 21 July 2026