Recruiting
Phase 1

T Lymphocytes

Sponsor:

Children's National Research Institute

Code:

NCT05238792

Conditions

Solid Tumor

Eligibility Criteria

Sex: All

Age: 1 - 70

Healthy Volunteers: Not accepted

Interventions

Tumor-associated antigen-specific T cell (TAA-T)

Study Details

Brief summary:

This is an open-label phase I dose-escalation study to evaluate the safety of partially human leukocyte antigen (HLA)-matched multi tumor-associated antigen-specific T cell (TAA-T) therapy following lymphodepleting conditioning with or without local tumor ablation for pediatric and adult patients with high-risk solid tumors due to the presence of refractory, relapsed and/or minimal residual detectable disease following conventional therapy (e.g., chemotherapy, surgery, radiation, autologous stem cell transplant, or targeted therapy).

Conditions

Solid Tumor

Study ID

NCT05238792

Start date

Nov 17, 2021

Status verified date

Jul, 2026

Completion date

Oct, 2029

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 70

Healthy Volunteers: Not accepted

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  • Diagnosis of high-risk solid tumors known to express at least 2 targeted antigens by either histology or historical reference: Ewing sarcoma, Wilms tumor, neuroblastoma, rhabdomyosarcoma, soft tissue sarcoma, and osteosarcoma.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

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TAA-T Infusion

Treatment with partially human leukocyte antigen (HLA)-matched multi tumor-associated antigen-specific T cell (TAA-T) therapy following lymphodepleting conditioning with or without local tumor ablation.

Interventions

Tumor-associated antigen-specific T cell (TAA-T)

Patients will receive cells due to the presence of refractory disease, or high risk for disease relapse and/or minimal residual detectable disease following conventional therapy. The treatment schedule is as follows: Patients will receive an infusion of partially HLA-matched TAA-T any time >1 week after completing most recent course of conventional (noninvestigational) therapy for their disease. For patients enrolled to DL2 or DL3, they will receive protocol-described lymphodepletion (LD) chemotherapy (fludarabine and cyclophosphamide) >2 weeks from most recent course of conventional therapy and post nadir and recovery from the prior therapy. Patients will be enrolled to one of the following TAA-T dose levels:

BSA <1.20 Dose Level 2 (+/- ablation + low dose TAA-T cells) 2x10\^7 Dose Level 3 (+/- ablation + high dose TAA-T cells) 4x10\^7

BSA>=1.20 Dose Level 2 (+/- ablation + low dose TAA-T cells) 4x10\^7 Dose Level 3 (+/- ablation + high dose TAA-T cells) 8x10\^7

Primary outcome measure

  • To determine the safety of administering partially HLA-matched TAA-T cells [ Time Frame: 45 days ]

Central Contacts and Locations

Central contacts

Amy Hont, MD

202-476-3887ahoughte@childrensnational.org

Fahmida Hoq, MBBS

202-476-3634fhoq@childrensnational.org

Locations

Children's National Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Amy Hont, MBBS, MS

202-476-3887ahoughte@childrensnational.org

Principal Investigator:

Amy Hont, MD

More Information

Sponsor

Children's National Research Institute

Last update posted

Aug 4, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's National Research Institute on 2026-08-04.