HER2 Chimeric Antigen Receptor (CAR) T Cells in Combination With Checkpoint Blockade in Patients With Advanced Sarcoma

The purpose of this study is to learn whether it is safe to give HER2-CAR T cells in combination with an immune checkpoint inhibitor drug (pembrolizumab or nivolumab), to learn what the side effects are, and to see whether this therapy might help patients with sarcoma. Another goal of this study is to study the bacteria found in the stool of patients with sarcoma who are being treated with HER2 CAR T cells and immune checkpoint inhibitor drugs to see if the types of bacteria influence how well the treatment works. The investigators have found from previous research that they can put a new ge

Trial Details

NCT ID
NCT04995003
Phase
PHASE1
Sponsor
Baylor College of Medicine
Status
RECRUITING
Cancer Type
Osteosarcoma Sarcoma
Interventions
  • T cells or CAR T cells
  • Pembrolizumab Injectable Product
  • Nivolumab Injectable Product
Locations (sample)
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • Diagnosis of a HER2-positive sarcoma. Immunohistochemistry (IHC) will be used to determine HER2 expression. Standard HER2 positive breast cancer de…
  • Age between 1 to 25 years
  • Karnofsky or Lansky performance score of ≥ 60
  • Informed consent explained to, understood by, and signed by patient/guardian. Patient or guardian given copy of informed consent.

For full eligibility, visit ClinicalTrials.gov.

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