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Study identifier: NCT07172958 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Rhabdomyosarcoma · Ewing Sarcoma · Neuroblastoma  ·  Sponsor: Children's National Research Institute

PhasePhase 1
Planned participants18
Who can joinAll sexes, 1 Year to 23 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Holly Meany, MD  ·  2024765697  ·  HMeany@childrensnational.org

Fahmida Hoq, MBBS  ·  2024763634  ·  FHoq@childrensnational.org

Always discuss trial participation with your own doctor first.

Locations (2)

Children's National HospitalWashington D.C., District of Columbia, United StatesRecruiting
Childrens National HospitalWashington D.C., District of Columbia, United StatesNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT07172958