Study on B7-H3-CAR T Cell Therapy After Initial Chemotherapy for High-Risk Osteosarcoma

Sponsor: St. Jude Children's Research Hospital

Sponsor score: 60

ClinicalTrials ID:NCT07428993

Provider View

This clinical trial is testing a new treatment using B7-H3-CAR T cells for patients with newly diagnosed high-risk osteosarcoma who have already received standard chemotherapy. The study aims to see if this treatment is safe and effective in preventing the cancer from returning.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new treatment called B7-H3-CAR T cell therapy for patients with high-risk osteosarcoma, a type of bone cancer. This treatment is given after patients have completed their initial chemotherapy. The main goal is to see if this therapy can help prevent the cancer from coming back within a year. The study will also look at overall survival rates and how feasible it is to deliver this therapy after standard treatment.

Description

This study involves a new treatment for patients with high-risk osteosarcoma, a type of bone cancer. Participants will first receive standard chemotherapy, which may include drugs like methotrexate, anthracycline, and platinum, along with surgery to remove the tumor and any lung metastases if needed. After this, patients will undergo a procedure to collect their blood cells, which will be used to create the B7-H3-CAR T cells in the lab.

Once the B7-H3-CAR T cells are ready, patients will receive a short course of chemotherapy to prepare their body, followed by the infusion of the B7-H3-CAR T cells. The study will test two different timing schedules for this treatment to see which is more effective. Patients will be monitored closely for two years to check for any signs of cancer returning and to assess their overall health.

The study aims to determine if this new therapy can improve outcomes for patients with high-risk osteosarcoma by reducing the chance of the cancer coming back and increasing survival rates.

Eligibility Criteria

Inclusion Criteria

  • Signed informed consent by the participant or their legal representative.
  • Completed all planned cycles of standard chemotherapy recently.
  • No signs of cancer progression since joining the study.
  • Good overall health with a performance status score of 50 or higher.
  • Adequate organ function, including:
    • Normal kidney function.
    • Acceptable liver function.
    • Healthy heart function.
    • Good breathing ability without extra oxygen.
  • Sufficient blood cell counts:
    • Neutrophil count of at least 750 cells/uL.
    • Platelet count of at least 75,000 (transfusions allowed).
    • Hemoglobin level of at least 7 g/dL (transfusions allowed).
  • At least 7 days since receiving high doses of steroids, except for necessary hormone replacement.
  • Signed informed consent for the treatment phase of the study.

Exclusion Criteria

  • Major surgical complications requiring ongoing care.
  • Significant brain or nerve problems.
  • Severe active infection, such as:
    • Positive blood culture or fever with infection signs within 48 hours of joining.
  • Previous cancer treatments other than the initial standard therapy.
  • Pregnant or breastfeeding.
  • Any condition that the study doctor believes would prevent safe participation in the study.

Locations

FACILITYZIPCITYSTATE
St. Jude Children's Research Hospital38105-2794MemphisTennessee

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