RecruitingPhase 1NCT07172958

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

Selective Antigen Specific dTβRII-expressing T Cells and B7-H3 CAR T Cells in Subjects With Relapsed/Refractory Embryonal Tumors (SABRE)

Sponsor

Children's National Research Institute

Enrollment

18 participants

Start Date

Jan 27, 2026

Study Type

INTERVENTIONAL

Conditions

Ewing Sarcoma Neuroblastoma Rhabdomyosarcoma Wilms Tumor

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.

Eligibility

Min Age: 1 YearMax Age: 23 Years

Plain Language Summary

Simplified for easier understanding

This trial (SABRE) is testing a specialized immune cell therapy for children and young adults with hard-to-treat childhood cancers including rhabdomyosarcoma (a muscle tumor), Ewing sarcoma (a bone tumor), neuroblastoma (a nerve tumor), and Wilms tumor (a kidney tumor). The therapy uses engineered T cells — a type of immune cell — to attack the cancer. **You may be eligible if...** - You are between 1 and 23 years old (and weigh more than 10 kg) - You have relapsed or treatment-resistant rhabdomyosarcoma, Ewing sarcoma, neuroblastoma, or Wilms tumor - Your cancer is still detectable after standard treatment or you cannot tolerate standard treatments - You have adequate blood counts and organ function **You may NOT be eligible if...** - You have taken systemic steroids within 1 week of the blood collection procedure - Your blood counts or organ function are significantly impaired - You are pregnant or unable to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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