Phase 1 Study of B7-H3 CAR T-Cell Therapy for Children and Young Adults With B7-H3-Positive Solid Tumors

What this Trial Is About

Researchers are investigating an immunotherapy called B7-H3-CAR T cells for patients 21 years old or younger with relapsed or refractory B7-H3-positive solid tumors. This Phase I clinical trial aims to find the highest safe dose of these genetically modified T cells and assess their safety and anti-tumor effects. The study also explores changes in the tumor environment and immune system after treatment. Participants receive a single infusion of B7-H3-CAR T cells following a short course of chemotherapy to reduce immune cells, with dosing based on the number of CAR-positive T cells and patient weight. The study uses a standard 33 dose escalation design and monitors patients over a 6-week evaluation period. After one year in the study, patients can join a long-term follow-up program to monitor safety. During the study, patients will be closely observed for side effects and treatment impact on their cancer. Researchers will assess safety six weeks after the infusion and evaluate clinical response. The study includes regular monitoring of heart, kidney, and lung function, blood tests, and performance status assessments. Participants may also provide biological samples to study immune changes. The total participation time is one year, followed by long-term safety monitoring.

B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)