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NCT07172958 · ClinicalTrials.gov registry record · Phase 1
Selective Antigen Specific T Cells and CAR T Cells in Subjects With Relapsed/Refractory Embryonal Tumors (SABRE)
A Phase 1 study of Neuroblastoma and Rhabdomyosarcoma, sponsored by Children's National Research Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 2
- Study locations
NCT07172958: Recruiting Phase 1 study of Neuroblastoma and Rhabdomyosarcoma, sponsored by Children's National Research Institute.
NCT07172958 is a Phase 1 study of Neuroblastoma and Rhabdomyosarcoma that is actively recruiting participants, run by Children's National Research Institute. The registered enrollment target is 18 participants, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07172958, a Phase 1 study of Neuroblastoma and Rhabdomyosarcoma, is actively recruiting participants, sponsored by Children's National Research Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
The safety endpoint will be assessed by monitoring for dose limiting toxicities (DLT) for 28 days following CAR-TA T cell investigational product administration.
Conditions Studied
Interventions
- BIOLOGICAL Selective Antigen Specific dTβRII-expressing T cells combined with B7-H3 CAR T cells
Study Locations (2)
District of Columbia
- Children's National Hospital - Washington D.C.
- Childrens National Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2026-01-27 |
| Est. Completion | 2038-12 |
| Phase | Phase 1 |
What NCT07172958 shows while recruiting
NCT07172958 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (92% lower).
The record links to 4 conditions, with Neuroblastoma appearing as the primary indexed condition, and to 1 intervention - of which Selective Antigen Specific dTβRII-expressing T cells combined with B7-H3 CAR T cells is the first listed.
NCT07172958 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT07172958 about?
NCT07172958 is a clinical study titled "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...
What is the current status of trial NCT07172958?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2026-01-27. Estimated completion is 2038-12.
What conditions does trial NCT07172958 study?
This clinical trial studies the following conditions: Neuroblastoma, Rhabdomyosarcoma, Ewing Sarcoma, Wilms Tumor.
What interventions are being tested in trial NCT07172958?
The interventions under investigation include: Selective Antigen Specific dTβRII-expressing T cells combined with B7-H3 CAR T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT07172958?
This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07172958 being conducted?
This trial has 2 study locations across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neuroblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07172958's enrollment target sits among peer trials
18 77th of 94 higher than 14 of 94 other Neuroblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neuroblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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