Engineered immune cells take aim at childhood cancer
NCT ID NCT00085930
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This study tested a new treatment for children with high-risk neuroblastoma, a type of cancer. Researchers took the patients' own immune cells (T cells) and modified them to recognize and attack the cancer. Some of these cells were also trained to fight a common virus (EBV) to help them last longer in the body. The main goal was to see if this treatment was safe and to learn how long the cells survived.
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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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19 people
The number who actually took part.
- Start date
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Apr 2003
- Finished
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Aug 2025
- 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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Up to 21 years
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: High risk neuroblastoma with a history of persistent or relapsed disease, or after initial therapy Patients must have a life expectancy of at least 12 weeks Patients must have recovered from the toxic effects of all prior chemotherapy before entering this study Patients must not be currently receiving any investigational agents or have not received any tumor vaccines within the previous 6 weeks Patients must have an ANC \> 500, platelet count \> 20,000 Patients who have received prior therapy with murine antibodies must have documentation of absence of human anti-mouse antibodies (HAMA) prior to enrollment on this study Patients must have bilirubin less than 3 times the upper limit of normal Patients must have AST less than 5 times the upper limit of normal Patients must have serum creatinine less than 3 times upper limit of normal Patient may not have cardiomegaly or bilateral pulmonary infiltrates on chest radiograph. Patients may have pulmonary metastatic lesions Patient may not have an oxygen requirement as defined by pulse oximetry of \> 90% on room air Patients must have Karnofsky score of \> 60% if \> 10 years old or Lansky performance score of greater than 60% if 10 years old or younger Patients must have autologous transduced EBV-specific CTLs and transduced peripheral blood T-cells with 15% expression or greater of 14g2a.zeta determined by flow-cytometry Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 3 months after the study is concluded. The male partner should use a condom Patients must not be pregnant or lactating Patients must not have tumor in a location where enlargement could cause airway obstruction Patients must not have a history of hypersensitivity to murine protein-containing products Patients must not have a known sensitivity to rat monoclonal antibodies Note: All labs must be collected within 10 days prior to initiation of study related treatment Exclusion Criteria: * Patients not meeting eligibility criteria
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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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Texas Children's Hospital
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a shorter chemo combo tame High-Risk neuroblastoma?
- Can a radioactive 'Smart Bomb' take down resistant childhood cancers?