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Multi Tumor-Associated Antigen-Specific T Lymphocytes for High-Risk Solid Tumors

This study is testing a new treatment called Tumor-associated antigen-specific T cell (TAA-T) therapy for patients aged 6 to 70 with high-risk solid tumors that have returned, are hard to treat, or have small amounts of disease left after standard treatments. These tumors include Ewing sarcoma, Wilms tumor, neuroblastoma, rhabdomyosarcoma, soft tissue sarcoma, and osteosarcoma. The TAA-T therapy uses your own immune cells, called T cells, to target specific markers on cancer cells. The main goal is to see how safe TAA-T therapy is, especially looking at any side effects within 45 days after treatment. Some patients will also receive chemotherapy before the TAA-T infusion to help the treatment work better. The study plans to enroll 36 participants.

Study design
This is a Phase I dose-escalation study, meaning different doses of the TAA-T therapy will be tested for safety. It will enroll 36 participants in two age groups.
What's involved
You will receive an infusion of TAA-T therapy after completing your previous conventional cancer treatment. Some participants will also receive lymphodepletion (LD) chemotherapy before the TAA-T infusion.
Compensation
Not stated in the trial record.
Follow-up
The study will measure the rate of toxicities (side effects) after TAA-T infusion at 45 days.

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NCT05238792

Multi Tumor-Associated Antigen-Specific T Lymphocytes to Treat Patients With High Risk Solid Tumors

Recruiting
PHASE1Ages 1–70InterventionalTreatment
Children's National Research Institute
~24 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:Tumor-associated antigen-specific T cell (TAA-T)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To determine the safety of administering partially HLA-matched TAA-T cells
Measured over 45 days

Conditions

Solid Tumor

Explore related trials

Ewing SarcomaNeuroblastomaOsteosarcomaRhabdomyosarcomaSoft Tissue SarcomaSolid NeoplasmWilms TumorHLA ComplexTumor Antigen

Where it's being run

1 sites across 1 states
District of Columbia1

Who to contact

Amy Hont, MD
[email protected]
202-476-3887
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • To determine the safety of administering partially HLA-matched TAA-T cells45 days

    Safety will be evaluated by the incidence of dose-limiting toxicities (DLTs).