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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 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.

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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.

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

FieldValue
Enrollment Target 18 participants
Start Date 2026-01-27
Est. Completion 2038-12
Phase Phase 1

What the Registry Record Tells You About NCT07172958

The ClinicalTrials.gov registry entry for NCT07172958 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (92% lower). The listed sponsor is Children's National Research Institute, which has 92 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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