Actively Recruiting
Selective Antigen Specific T Cells and CAR T Cells in Subjects With Relapsed/Refractory Embryonal Tumors (SABRE)
Led by Children's National Research Institute · Updated on 2026-01-27
18
Participants Needed
2
Research Sites
670 weeks
Total Duration
On this page
Sponsors
C
Children's National Research Institute
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase I dose-escalation study to determine the safety and feasibility of autologous CAR-TA T cells (B7-H3 CAR+ T cells administered with DNR-PRAME Tumor Antigen-specific T cells) following lymphodepleting chemotherapy in participants with relapsed/refractory rhabdomyosarcoma, Ewing sarcoma, neuroblastoma and Wilms tumor. Patients will be enrolled to one of three planned dose levels with B7-H3 CAR T cell dose determined based on the percentage of B7-H3 transduced cells (B7-H3+ population of cells), and dTBRII-transduced PRAME TA-specific T cell dose based on the total cell population. Both doses will be based on the recipient's body weight. The safety of the CAR-TA T cell product will be evaluated and the maximum tolerated dose (MTD) will be determined. The safety endpoint will be assessed by monitoring for dose limiting toxicities for 28 days following CAR-TA T cell administration.
CONDITIONS
Official Title
Selective Antigen Specific T Cells and CAR T Cells in Subjects With Relapsed/Refractory Embryonal Tumors (SABRE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsed or refractory rhabdomyosarcoma, Ewing sarcoma, neuroblastoma, or Wilms tumor
- Disease is measurable or evaluable by imaging after most recent therapy
- Age 1 year or older and less than 24 years
- Weight greater than 10 kg
- No systemic steroid use within 1 week before procurement or therapy
- Karnofsky or Lansky performance score of 60 or higher
- Agreement to use effective contraception during the study and for 6 months after CAR-TA T cell administration if of childbearing potential
- Absolute neutrophil count (ANC) greater than 500/µL for procurement and greater than 750/µL for infusion
- Absolute lymphocyte count (ALC) greater than 1000/µL for procurement
- Platelet count greater than 50,000/µL for procurement and greater than 75,000/µL for infusion (transfusion allowed)
- Bilirubin 2.5 mg/dL or less
- AST and ALT levels no more than 5 times the upper limit of normal for age
- Serum creatinine within age and sex specific limits or creatinine clearance/GFR 70 mL/min/1.73 m2 or higher
- Negative pregnancy test for females of childbearing potential
- Pulse oximetry over 90% on room air
- Adequate cardiac function by echocardiogram or radionuclide angiogram
- No acute neurological toxicity higher than grade 1 (except controlled seizure or peripheral sensory neuropathy)
- Required time intervals since prior therapies before apheresis or protocol therapy
- Ability of patient or guardian to provide informed consent
You will not qualify if you...
- Known central nervous system disease
- Uncontrolled infections or known HIV infection
- Pregnancy or lactation
- Previous allogeneic stem cell transplant
- Whole lung or mediastinal radiation within 12 weeks before therapy
- Clinically significant systemic illness or medical condition interfering with safety or efficacy assessments
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
2
Childrens National Hospital
Washington D.C., District of Columbia, United States, 20010
Not Yet Recruiting
Research Team
H
Holly Meany, MD
CONTACT
F
Fahmida Hoq, MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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