Experimental immune cell therapy takes aim at childhood cancers
NCT ID NCT05238792
First seen Jun 25, 2026 · Last updated Aug 05, 2026 · Updated 3 times
Summary
This early-stage study tests whether giving children with high-risk solid tumors a special type of immune cell (called TAA-T) is safe. The cells are designed to recognize and attack proteins found on tumor cells. Up to 36 children whose cancer has not responded to standard treatments will receive these cells, and researchers will monitor for side effects and any signs of tumor shrinkage.
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-specific T cells (TAA-T)
- What this could lead to
- If successful, this could point toward a new immune-based treatment option for children with hard-to-treat solid tumors that have not responded to standard therapy.
- What could go wrong
- This is a very early Phase 1 safety trial with only 36 participants. The treatment may cause serious side effects like graft-versus-host disease or infusion reactions, and it is not yet known if it will shrink tumors or improve survival.
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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 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2021
- Expected to finish
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Oct 2029
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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1 year to 70 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: * Diagnosis of high-risk solid tumors known to express at least 2 targeted antigens by either histology or historical reference: Ewing sarcoma, Wilms tumor, neuroblastoma, rhabdomyosarcoma, soft tissue sarcoma, and osteosarcoma. * HLA type and match through at least one allele with antigen-specific activity. * Following conventional therapy: refractory disease, residual detectable disease, or relapsed disease. * Age \>= 1 year and \<70 years * Patient or parent/guardian capable of providing informed consent. * No systemic corticosteroid exposure within 1 week of initiating protocol treatment. * Karnofsky/Lansky score of ≥50%. * For participant with history of total body irradiation (TBI), radiation to thorax, or treatment with cardiotoxic chemotherapy (anthracycline or equivalent): Left ventricular ejection fraction (LVEF) \>50% OR left ventricular fractional shortening (FS) \>27% (may be performed within the last 12 months, and after completion of such treatment/s) * Hemoglobin \>7.0 g/dL (level can be achieved with transfusion). * Direct bilirubin ≤2.5 mg/dL or 3x ULN (whichever is higher). * Aspartate transaminase (AST)/Alanine transaminase (ALT) ≤5 x 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. * Respiratory rate: * \<30 breaths per minute for patients aged \<18 years * \<25 breaths per minute for patients aged ≥18 years * Respiratory rate may be repeated if initial value is thought to be temporarily abnormal. If repeated, 2 values should be obtained ≥30 minutes apart prior to protocol treatment to be eligible. * Twelve (12) weeks post last radiation dose to the mediastinum/chest with resolution of any respiratory symptoms. * Negative pregnancy test in female patient of childbearing potential. * Agree to use contraceptive measures during study protocol participation through 6 months post final TAAT infusion (for FOCBP). * Prior to cycle #1 only (requisite for receiving lymphodepleting chemotherapy): * Absolute neutrophil count (ANC) \>1000 /ul. * Platelet count \>75,000 /ul. Exclusion Criteria: * Patients with uncontrolled infections. Uncontrolled infections are defined as bacterial, fungal, or viral infections with either clinical signs of worsening despite standard therapy. Progressing infection is defined as hemodynamic instability, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection. * For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection within 7 days prior to protocol treatment. * For fungal infections, patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection within 7 days prior to initiating protocol treatment. * Patients who received ATG, Campath or other immunosuppressive T cell monoclonal antibodies within 28 days prior to initiating protocol treatment. * Exposure to chemotherapy or immunomodulatory medications within the last 2 weeks prior to initiating protocol treatment. * 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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Children's National Hospital
RECRUITINGWashington D.C., District of Columbia, 20010, United States
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- A pill that blocks RAS: can it help children whose tumors came back?
- Proton boost radiotherapy aims to hit large tumors harder while sparing healthy tissue
- New antibody aims to preserve immune checkpoint while fighting cancer