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3CAR4OS: CAR T–Cell Therapy for High‑risk Osteosarcoma

About this study 

Osteosarcoma is a type of bone cancer that can spread to other parts of the body, often the lungs. Children and young adults with high‑risk osteosarcoma usually receive strong chemotherapy and surgery. Even with this treatment, the cancer can come back. Doctors need better treatments that may help patients live longer and lower their risk of cancer coming back (relapse). 

This study tests a treatment called B7‑H3 CAR T–cell therapy. This treatment is a type of immunotherapy. CAR T‑cell therapy uses a patient’s own immune cells, called T cells. These cells are changed in a lab so they can better find and attack cancer cells. In this study, the CAR T cells are made to target a protein called B7‑H3, a “marker” that is found on the surface of some tumor cells. Many osteosarcoma cancer cells have this protein. Earlier studies show these CAR T cells can recognize and attack osteosarcoma cells and may be safe to use. 

People in this study will first receive standard chemotherapy and surgery for osteosarcoma. Blood cells are collected earlier in treatment to make the B7‑H3 CAR T cells in the lab. After chemotherapy ends, patients receive a short course of chemotherapy to prepare their body. Then they receive 1 infusion of B7‑H3 CAR T cells. Some patients will have surgery to remove lung tumors before or after the CAR T–cell treatment. 

Doctors and researchers will watch patients closely during and after treatment. They will check how the treatment works and look for side effects, such as cytokine release syndrome. 

Researchers hope this treatment helps the immune system stop cancer from growing or coming back after standard treatment ends. The study will look at how many patients remain free of cancer 1 year after receiving CAR T–cell therapy. Researchers will also study safety, overall survival, and whether this treatment can be given successfully after chemotherapy. 

This research may help doctors learn if B7‑H3 CAR T–cell therapy could become a new treatment option for people with high‑risk osteosarcoma. More information is still needed to understand how safe it is, how well it works over time, and which patients may benefit most. 

Eligibility overview 

  • 0–21 years old 
  • Osteosarcoma that has spread to the lungs 
  • Cancer tumor has the B7-H3 marker 

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The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

Overview

Full title:

3CAR4OS: A Phase 2 Study Evaluating the Efficacy of B7‑H3 CAR T Cells Administered at the End of Upfront MAP Chemotherapy in Patients with Newly Diagnosed High‑risk Osteosarcoma

Study goal:

To study B7‑H3 CAR T cells given after standard therapy to reduce relapse risk in high‑risk osteosarcoma.

Diagnosis:

Osteosarcoma

Age:

0–21 years

Clinical trial categories:

Childhood Cancer Osteosarcoma

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.

 

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