A Phase 1, First in Human Study of Adenovirally Transduced Autologous Macrophages Engineered to Contain an Anti-HER2 Chimeric Antigen Receptor in Subjects With HER2 Overexpressing Solid Tumors

Biopsy samples from 4 sites were collected for RNA-Seq and single-cell RNA-Seq from patients with HER2 positive tumors enrolled in a Phase 1 clinical trial of anti-HER2 CAR-macrophage cell therapy. Biopsies of solid tumors were aimed to be collected at screening, 8 days after treatment, and 4 weeks after treatment. Patients in Group 1 received dose escalation of intravenous administration of up to 500 million cells, 1.5 billion cells, and 3 billion cells, on Day 1, 3, and 5, respectively. Patients in Group 2 received their full dose of cells on Day 1. This trial aimed to determine the feasibility of manufacturing CAR-macrophages, as well as assess the safety and tolerability of CAR-macrophage therapy, and determine the severity of potential adverse events.