Using T cells to treat high-risk solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I dose-escalation trial evaluates the safety of partially HLA-matched multi tumor-associated antigen-specific T cell (TAA-T) therapy for patients with high-risk solid tumors that have not responded to conventional treatments. The study includes two arms based on age, with patients receiving TAA-T therapy after a lymphodepleting chemotherapy regimen. The trial aims to assess both the safety and anti-tumor activity of the TAA-T product across different dose levels. Participants will be monitored for their response to the treatment following their previous therapies.

Why it matters

Who can join: the full rules

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* Diagnosis of high-risk solid tumors known to express at least 2 targeted antigens by either histology or historical reference: Ewing sarcoma, Wilms tumor, neuroblastoma, rhabdomyosarcoma, soft tissue sarcoma, and osteosarcoma.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.

Where it's running

• Children's National Hospital
  Washington D.C., District of Columbia, United States Recruiting

Study contacts

• Study coordinator: Amy Hont, MD
• Email: ahoughte@childrensnational.org
• Phone: 202-476-3887

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.