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.
Age range
1 Year – 23 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Grade 3 or more immediate infusion-related adverse event
Timeframe: Within 28 days from the CAR-TA T cell infusion
Grade 4 or more Immune Effector Cell Associated Neurotoxicity Syndrome (ICANS)
Timeframe: Within 28 days from the CAR-TA T cell infusion
Grade 3 neurotoxicity or ICANS persisting for more than 72 hours
Timeframe: Within 28 days from the CAR-TA T cell infusion
Grade 4 or more Cytokine Release Syndrome (CRS)
Timeframe: Within 28 days from the CAR-TA T cell infusion
Grade 3 Cytokine Release Syndrome (CRS) lasting more than 14 days
Timeframe: Within 28 days from the CAR-TA T cell infusion
Grade 3 or more Hemophagocytic Lymphohistiocytosis (HLH)
Timeframe: Within 28 days from the CAR-TA T cell infusion
Grade 3 or more fever lasting for more than 14 days
Timeframe: Within 28 days from the CAR-TA T cell infusion
Grade 4 or more infection uncontrolled for more than 7 days
Timeframe: Within 28 days from the CAR-TA T cell infusion
Any unexpected toxicity of Grade 2 or more
Timeframe: Within 28 days from the CAR-TA T cell infusion
Any expected toxicity above Grade 4
Timeframe: Within 28 days from the CAR-TA T cell infusion
Any expected toxicity above Grade 3 lasting longer than 72 hours
Timeframe: Within 28 days from the CAR-TA T cell infusion
Grade 2 toxicity persisting for more than 7 days AND considered intolerable to the patient and/or not controlled with standard supportive care
Timeframe: Within 28 days from the CAR-TA T cell infusion