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

Study acronym: SABRE
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 years 11 months later Dec 2035 → Dec 2041
Primary endpoints removed 12 → 3 primary endpoints
See other at-risk trials from Children's National Research Institute

Record History

  1. Primary completion pushed from Dec 2035 to Dec 2041 Primary endpoint(s) modified · Completion pushed from Dec 2038 to Dec 2044 · Eligibility criteria expanded, about 228 words · 4 morev5 Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Completion pushed from Dec 2038 to Dec 2044
    • Eligibility criteria expanded, about 228 words
    • Secondary endpoints: 3 to 11
    • Study description revised
    • Site contacts updated at 1 of 2 sites
    • Collaborators: 3 to 2

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv4
  3. Trial status: Not Yet Recruiting to Recruiting Start date: Oct 22, 2025 to Jan 27, 2026 · Study sites: 1 to 2v3 Show 2 more changesShow less
    • Start date: Oct 22, 2025 to Jan 27, 2026
    • Study sites: 1 to 2
  4. Primary endpoints revised (12) Secondary endpoints: details revised at 3 of 3 entriesv2 Show 1 more changeShow less
    • Secondary endpoints: details revised at 3 of 3 entries

    See this version in full on ClinicalTrials.gov ↗

  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 and combined in a 1:1 ratio. 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.
Trial Details
NCT Number NCT07172958
Lead Sponsor Children's National Research Institute
Collaborators: National Cancer Institute (NCI), Cancer Research UK
Conditions Rhabdomyosarcoma, Ewing Sarcoma, Neuroblastoma, Wilms Tumor
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov