Hypofractionated Radiation in Combination With B7-H3-CAR T Cells for Pediatric Patients With Relapsed/Refractory Sarcomas

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT07222735
Phase
PHASE1
Status
Recruiting
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Conditions

  • Childhood Osteosarcoma
  • Childhood Rhabdomyosarcoma
  • Childhood Soft Tissue Sarcoma
  • Ewing Sarcoma
  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Fludarabine — DRUG
    Intravenously on day -5, -4, -3 and -2
  • Cyclophosphamide — DRUG
    Intravenously on day -3, -2
  • B7-H3-CAR T Cells — DRUG
    Intravenously on day 0
  • Radiation Therapy — RADIATION
    5 or 8 treatment sessions (fractions), scheduled to complete on Day -2

Study Details

RAD3CAR is a phase I study designed to evaluatethe safety of B7-H3-CAR T cells and lymphodepletion in combination with hypofractionated radiation therapy. Primary objective: \- To evaluate the safety of B7-H3-CAR T cell therapy after priming with hypofractionated radiation therapy (HFRT) and lymphodepleting chemotherapy in patients ≤ 21 years of age with relapsed/refractory B7-H3+ sarcomas. Secondary objectives: * To describe the antitumor activity of B7-H3-CAR T cells in combination with HFRT * To determine if B7-H3-CAR T cells traffic to tumor sites after combination treatment with HFRT

Key Dates

Start date
Jan 21, 2026
Status verified
Feb 2026
Primary completion
Nov 5, 2030
Completion
Nov 5, 2031

Study Design

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

Arms

  • Experimental: RAD3CAR Treatment
    Peripheral blood mononuclear cells (PBMC) will be collected by autologous apheresis. Treatment will include HFRT to at least one site of disease, administered in parallel with a single course of lymphodepleting chemotherapy (fludarabine/cyclophosphamide) and followed by CAR T cell infusion.

Primary Outcome Measure

Dose limiting toxicity (DLT) rate [ Time Frame: up to 4 weeks after CAR T cell infusion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105
Rebecca Epperly, MD
[email protected]
866-278-5833
Rebecca Epperly, MD (PRINCIPAL_INVESTIGATOR)

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By research site
St. Jude Children's Research Hospital· Memphis, TN

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