Actively Recruiting
Multi Tumor-Associated Antigen-Specific T Lymphocytes to Treat Patients With High Risk Solid Tumors
Led by Children's National Research Institute · Updated on 2026-03-12
36
Participants Needed
1
Research Sites
410 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a 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 for patients with high-risk solid tumors due to the presence of refractory, relapsed and/or minimal residual detectable disease following conventional therapy. Conventional therapy may include chemotherapy, surgery, radiation, autologous stem cell transplant, or targeted therapy.
CONDITIONS
Official Title
Multi Tumor-Associated Antigen-Specific T Lymphocytes to Treat Patients With High Risk Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of high-risk solid tumors known to express at least 2 targeted antigens such as Ewing sarcoma, Wilms tumor, neuroblastoma, rhabdomyosarcoma, soft tissue sarcoma, or osteosarcoma
- HLA type matches at least one allele with antigen-specific activity
- Disease is refractory, has residual detectable disease, or has relapsed after conventional therapy
- Age 18 to under 70 years for Arm A
- Age 6 to under 18 years for Arm B
- Patient or parent/guardian able to provide informed consent
- No systemic steroid use within 1 week before TAA-T infusion
- Karnofsky/Lansky score of 50% or higher
- Left ventricular ejection fraction greater than 50% or LV systolic dysfunction over 27% if history of total body irradiation
- Hemoglobin greater than 7.0 g/dL (transfusion allowed)
- Bilirubin 2.5 mg/dL or less
- AST/ALT up to 5 times the upper limit of normal for age
- Serum creatinine less than 1.0 mg/dL or up to 2 times upper limit of normal for age
- Pulse oximetry over 90% on room air
- Negative pregnancy test for females of childbearing age
- Use of contraceptive measures during study if age appropriate
- For patients receiving lymphodepleting chemotherapy: ANC over 1000 /ul and platelet count over 75,000 /ul
You will not qualify if you...
- Known HIV infection
- Pregnant or breastfeeding females
- Previous allogeneic stem cell transplant
- Previous autologous stem cell transplant within the past 60 days
- Uncontrolled infections with worsening signs despite therapy
- Receiving immunosuppressive T cell monoclonal antibodies (e.g., ATG, Campath) within 28 days before TAA-T infusion
- For lymphodepleting chemotherapy patients: chemotherapy or immunomodulatory medication within 2 weeks before treatment
- Pregnant or lactating females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
Research Team
A
Amy Hont, MD
CONTACT
F
Fahmida Hoq, MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here