Selective Antigen Specific T Cells and CAR T Cells in Subjects With Relapsed/Refractory Embryonal Tumors (SABRE)

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

Trial Details

NCT ID
NCT07172958
Phase
PHASE1
Sponsor
Children's National Research Institute
Status
RECRUITING
Cancer Type
Kidney Cancer
Interventions
  • Selective Antigen Specific dTβRII-expressing T cells combined with B7-H3 CAR T cells
Locations (sample)
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637

Key Eligibility Criteria

  • 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 …
  • Measurable or evaluable disease by imaging, as determined following most recent therapy

For full eligibility, visit ClinicalTrials.gov.

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