RecruitingPhase 1NCT07222735

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


Sponsor

St. Jude Children's Research Hospital

Enrollment

42 participants

Start Date

Jan 21, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Max Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment for children and young adults with bone and soft tissue cancers (sarcomas) that have come back or stopped responding to standard treatment. It combines targeted immune cells called CAR T cells — specially engineered to attack a protein found on these tumors — with a focused radiation treatment to help the immune cells work better. **You may be eligible if...** - You are 21 years old or younger - You have been diagnosed with osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, or another soft tissue sarcoma - Your tumor tests positive for a protein called B7-H3 - Your cancer has come back or is not responding to standard first-line treatment - You are well enough to carry out some daily activities (performance score of 60 or above) - Your heart, kidneys, lungs, and liver are working adequately **You may NOT be eligible if...** - You have cancer that has spread to the brain or spinal cord - You have HIV or a serious immune system deficiency - You have an active, severe infection that is not controlled - You have another active cancer besides the sarcoma being treated - Your disease is progressing very rapidly 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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Interventions

DRUGFludarabine

Intravenously on day -5, -4, -3 and -2

DRUGCyclophosphamide

Intravenously on day -3, -2

DRUGB7-H3-CAR T Cells

Intravenously on day 0

RADIATIONRadiation Therapy

5 or 8 treatment sessions (fractions), scheduled to complete on Day -2


Locations(1)

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

View Full Details on ClinicalTrials.gov

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NCT07222735


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