Selective Antigen Specific T Cells and CAR T Cells in Subjects With Relapsed/Refractory Embryonal Tumors (SABRE)
Recruiting now · Phase 1
Conditions studied: Rhabdomyosarcoma, Ewing Sarcoma, Neuroblastoma, Wilms Tumor
In brief
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.
Key facts
- Study ID
- NCT07172958
- Run by
- Children's National Research Institute
- People needed
- 18
- Starts
- 2026-01-27
- Expected to finish
- 2038-12-01
- Last updated by the study team
- 2026-05-22
Who can join
Age: 1 and older, up to 23. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Recipient Inclusion Criteria for Procurement:
- Diagnosis of relapsed/refractory rhabdomyosarcoma, Ewing sarcoma, neuroblastoma, or Wilms tumor
- Refractory disease, residual detectable disease or relapsed disease following available standard of care therapies with known clinical benefit for their specific tumor type, or unable to receive such therapies due to unacceptable toxicity or contraindication
- Measurable or evaluable disease by imaging, as determined following most recent therapy
- Age ≥ 1 year and < 24 years
- Weight > 10 kg
- No systemic steroid exposure within 1 week of procurement
- Karnofsky/Lansky score of ≥ 60 (See Appendix 3)
- Participants of childbearing potential or capable of fathering a child must agree to use effective contraceptive measure/s (as described in Appendix 5) during study protocol participation through 6 months following the administration of the CAR-TA T cells
- ANC > 500/µL
- ALC > 1000/µL
- Platelet count > 50,000/uL (level can be achieved with transfusion)
- Bilirubin ≤ 2.5 mg/dL
- Aspartate aminotransferase (AST)/Alanine transaminase (ALT) ≤ 5x the upper limit of normal for age
- Serum creatinine Maximum serum creatinine (mg/dL) Age Male Female
- to < 2 years 0.6 0.6
- to < 6 years 0.8 0.8
- 6 to < 10 years 1 1 10 to < 13 years 1.2 1.2 13 to < 16 years 1.5 1.2
- ≥ 16 years 1.7 1.4 OR Creatinine clearance or glomerular filtration rate (GFR) ≥ 70 mL/min/1.73 m for patients with levels above
- For FOCBP: Negative pregnancy test
- Pulse oximetry of > 90% on room air
- Adequate cardiac function defined as: o Shortening fraction of ≥ 27% by echocardiogram, or o Ejection fraction of > 50% by echocardiogram or radionuclide angiogram (i.e., MUGA).
- No acute neurological toxicity > grade 1 (with the exception of peripheral sensory neuropathy or controlled seizure disorder on anti-epileptics).
- The following time frames must have elapsed between prior therapy completion and apheresis cell collection:
- Myelosuppressive chemotherapy/immunomodulatory medications: At least 3 weeks, or 6 weeks if prior nitrosourea.
You may not qualify if…
- Recipient Procurement Exclusion Criteria:
- Patients with known CNS disease.
- Patients with uncontrolled infection/s or known HIV infection
- Pregnant or lactating females.
- Patients who have undergone previous allogeneic stem cell transplant.
- Recipient Exclusion Criteria for CAR-TA T cell product Infusions:
- Patients with uncontrolled infections or known HIV infection.
- Pregnant or lactating females
- Whole lung/mediastinal radiation within 12 weeks
- Clinically significant systemic illness or medical condition likely to interfere with assessment of safety or efficacy
Where it is running
- Children's National Hospital — Washington D.C., District of Columbia, United States (enrolling)
- Childrens National Hospital — Washington D.C., District of Columbia, United States
Full record on ClinicalTrials.gov
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