HER2 Chimeric Antigen Receptor (CAR) T Cells in Combination WithCheckpoint Blockade in Patients With Advanced Sarcoma (HEROS 3.0)
Trial ID: NCT04995003
Phase: Phase 1
Status: Recruiting
Last Update Posted: January 2026
Eligibility: Patients aged 1 to 25 with advanced or recurrent synovial sarcoma expressing the HER2 protein who have progressed after at least one prior systemic therapy, have measurable disease, and a Karnofsky or Lansky performance score of at least 60.
Overview: This Phase 1 trial, sponsored by Baylor College of Medicine and led by Principal Investigators Meenakshi Hegde, MD, Shoba Navai, MD, and Nabil Ahmed, MD, investigates HER2-targeted CAR T-cell therapy combined with a checkpoint inhibitor in patients with advanced sarcoma including synovial sarcoma. A patient’s own T-cells are genetically modified to recognize HER2-expressing tumor cells. After lymphodepleting chemotherapy with cyclophosphamide and fludarabine, the modified T-cells are infused back into the patient. Starting one week later, patients receive either pembrolizumab (every three weeks) or nivolumab (every two weeks) to further activate the immune response against the cancer. Patients who tolerate the treatment well may receive additional T-cell infusions at 6 to 12 week intervals.
Preliminary Effectiveness: Early-phase studies of HER2-targeted CAR T-cell therapy in sarcoma have demonstrated safety and some clinical benefit in advanced patients. No formal results for this specific trial have been posted to ClinicalTrials.gov at this time.

Study Contact: Baylor College of Medicine

Treatment Centers:

  • Texas Children’s Hospital, Houston, TX