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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Children's National Research Institute
Study ID
NCT07172958
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 23 Years
Healthy Volunteers
Not accepted

Interventions

  • Selective Antigen Specific dTβRII-expressing T cells combined with B7-H3 CAR T cells — BIOLOGICAL
    Selective Antigen Specific dTβRII-expressing T cells combined with B7-H3 CAR T cells

Study Details

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.

Key Dates

Start date
Jan 27, 2026
Status verified
May 2026
Primary completion
Dec 31, 2035
Completion
Dec 31, 2038

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: This is single arm study.
    Lymphodepleting chemotherapy regimen with cyclophosphamide and fludarabine will be administered prior to CAR-TA T cell product infusion. The DNR-TA T cells and B7-H3 CAR T cells will be generated and combined into a final product comprised of the two T cell components combined at a 1:1 ratio.

Primary Outcome Measure

Grade 3 or more immediate infusion-related adverse event [ Time Frame: Within 28 days from the CAR-TA T cell infusion ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's National HospitalWashington D.C.District of Columbia20010
Fahmida Hoq, MBBS, MS
[email protected]
202-476-3634
Amy Hont, MD (SUB_INVESTIGATOR)
Childrens National HospitalWashington D.C.District of Columbia20010
Holly Meany, MD
[email protected]
202-476-5697
Holly Meany, MD (PRINCIPAL_INVESTIGATOR)
Amy Hont, MD (SUB_INVESTIGATOR)

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