Supercharged immune cells take on childhood cancers
NCT ID NCT02789228
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests a new type of cell therapy for children and young adults with solid tumors that have come back or not responded to standard treatments. The therapy uses a patient's own immune cells, which are trained in the lab to recognize and attack multiple cancer-related targets. The main goal is to see if this approach is safe, while also checking for any signs that the tumors shrink.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tumor associated antigen lymphocytes (TAA-CTL), a type of immune cell therapy
- What this could lead to
- If this works, it could point toward a new treatment option for children and young adults with hard-to-treat solid tumors that have not responded to standard therapy.
- What could go wrong
- This is a very early (Phase 1) and small study (28 participants) focused mainly on safety. The therapy may not shrink tumors or improve survival, and there is a risk of serious side effects like infusion reactions or graft-versus-host disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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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28 people
The number who actually took part.
- Started
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Oct 2016
- Expected to finish
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Dec 2027
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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6 months to 60 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.
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: Recipient procurement inclusion criteria * Diagnosis of high-risk solid tumors: Ewing sarcoma, Wilms tumor, neuroblastoma, rhabdomyosarcoma, soft tissue sarcomas, osteosarcoma, adenocarcinoma, and esophageal carcinoma and renal cell carcinoma. * Refractory disease, residual detectable disease following conventional therapy or relapsed disease. * 6 months to 60 years of age at enrollment.\* * Karnofsky/Lansky score of ≥ 50%.\* * Absolute neutrophil count (ANC) greater than 500/µL. \* * Absolute lymphocyte count (ALC) greater than 1000/µL.\* * Bilirubin ≤ 2.5 mg/dL. \* * Aspartate aminotransferase (AST)/ Alanine transaminase (ALT) ≤ 5x the upper limit of normal for age. \* * Serum creatinine \< 1.0 mg/dL or 2 x the upper limit of normal for age (whichever is higher).\* * Pulse oximetry of \> 90% on room air.\* * Agree to use contraceptive measures during study protocol participation (when age appropriate).\* * LVEF \> 50% or LVSF \> 27 % if history of total body irradiation (TBI). * Patient or parent/guardian capable of providing informed consent. Exclusion Criteria: Recipient Procurement exclusion criteria * Patients with uncontrolled infections * Patients with active HIV * Current evidence of GVHD \> grade 2 or chronic GVHD manifestations: bronchiolitis obliterans syndrome, sclerotic GVHD, or serositis. * Pregnant or lactating females * Prior immunotherapy with an investigational agent within the last 28 days prior to procurement Recipient Inclusion to administer cells: * Steroids less than 0.5 mg/kg/day prednisone (or equivalent). * Karnofsky/Lansky score of ≥ 50% %. * Bilirubin ≤ 2.5 mg/dL. * AST/ALT ≤ 5x the upper limit of normal for age. * Serum creatinine \< 1.0 mg/dL or 2x the upper limit of normal for age (whichever is higher). * Pulse oximetry of \> 90% on room air. * Patients receiving lymphodepleting chemotherapy must have: ANC \>750 /uL Platelet count \>75,000 /uL Recipient Exclusion to administer cells: * Patients with uncontrolled infections * Patients who received ATG, Campath, or other T cell immunosuppressive monoclonal antibodies within 28 days prior to TAA-T cell infusion * Acute GVHD \> grade 2 or chronic GVHD manifestations: bronchiolitis obliterans syndrome, sclerotic GVHD, or serositis * Pregnant or lactating females
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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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Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
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