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New CAR T-cell therapy shows promise in treating aggressive HER2+ breast cancer
Last reviewed: 02.07.2025
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About a third of HER2-positive (HER2+) tumors express the P95HER2 protein, which is associated with a more aggressive course of breast cancer and a worse prognosis. Researchers from the Vall d'Hebron Oncology Institute (VHIO) and the Cancer Research Program of the Institute of Medical Research of the Hospital del Mar (Barcelona) have created a new chimeric antigen receptor T-cell therapy (CAR-T) that shows a powerful antitumor effect against cells expressing P95HER2.
Key Features of the New CAR-T Therapy
- CAR-T cells were modified to express the anti-P95HER2 receptor and secrete the bispecific antibody TECH2Me, which recognizes tumor cells and activates immune cells in the tumor microenvironment (TME).
- The new approach has demonstrated its efficacy and safety in models created based on tumor samples from patients with HER2+ tumors expressing P95HER2.
Results of preclinical study
The results, published in Nature Communications, showed complete and durable anti-tumor responses to the new CAR-T therapy in a subset of HER2+ tumors. In some cases, tumors disappeared completely, and the mice lived for several months without deterioration in quality of life.
"Developing CAR-T cells for the treatment of solid tumors requires new strategies that enhance the patient's immune response against cancer. We have created a new generation of CAR-T cells with additional therapeutic components for a more effective, long-lasting and safer effect," said Macarena Roman, lead author of the study.
Features and benefits of new CAR-T therapy
- Targeted: The new therapy targets the P95HER2 protein, which is not expressed in normal tissues, reducing the risk of toxicity.
- Additional components: CAR-T cells have been modified to secrete a bispecific antibody, BiTE®, which activates T cells and reduces toxicity to healthy cells with normal HER2 levels.
- Duration of effect: Using a patient-based tumor model, large tumors were completely reduced and the mice's quality of life was maintained.
Next steps and clinical trials
- Based on preclinical results, the approval process for the first Phase 1 clinical trial to evaluate the safety and efficacy of the therapy in patients with HER2+ tumors is being initiated.
- The trial will begin next year and will include 15 patients with HER2-associated tumors who have exhausted all available therapeutic options.