Engineered immune cells plus chickenpox vaccine take on childhood cancers
NCT ID NCT01953900
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a new treatment for advanced osteosarcoma and neuroblastoma that has not responded to standard therapy. Researchers take a patient's own immune cells (T cells), add a gene to help them recognize and attack cancer cells, and combine them with a chickenpox vaccine to help the cells last longer in the body. The main goal is to find a safe dose and understand side effects in about 26 participants.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2014
- Expected to finish
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Oct 2034
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Procurement: * Diagnosis of relapsed or refractory osteosarcoma OR relapsed or refractory high risk neuroblastoma not responsive to standard treatment. * Either previously infected with varicella zoster virus(VZV; chicken pox) or previously vaccinated with VZV vaccine * Karnofsky/Lansky score of greater than or equal to 50 * Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent Treatment: * Diagnosis of relapsed or refractory osteosarcoma OR relapsed or refractory high risk neuroblastoma not responsive to standard treatment. * Recovered from the acute toxic effects of all prior chemotherapy * Karnofsky/Lansky score of greater than or equal to 50 * Bilirubin less than or equal to 3x upper limit of normal, AST less than or equal to 5x upper limit of normal, Serum creatinine less than or equal to 2x upper limit of normal, Hgb greater than or equal to 7.0 g/dl, ANC\>500/uL, platelets \> 50,000/uL * Pulse oximetry of greater than or equal to 90% on room air * Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the CTL infusion. Male partner should use a condom. * Available autologous transduced cytotoxic T lymphocytes with greater than or equal to 20% expression of GD2 CAR and killing of GD2-positive targets greater than or equal to 20% in cytotoxicity assay * Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent Exclusion Criteria: Procurement: • Known primary immune deficiency or HIV positivity Treatment: * Severe intercurrent infection * Known primary immune deficiency or HIV positivity * Pregnant or lactating * History of hypersensitivity reactions to murine protein-containing products * Known allergy to VZV vaccine
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Houston Methodist Hospital
Houston, Texas, 77030, United States
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Texas Children's Hospital
Houston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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