CAR-macrophage therapy for HER2-overexpressing advanced solid tumors: a phase 1 trial

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. TCR Sequencing was performed by Adaptive Biotechnologies on patient tumor biopsies at Screening, 8 days post CAR-Macrophage infusion, and 4 weeks post-infusion. TCR-Sequencing was performed on patient blood samples at Screening, 8 days, 15 days, and 4 weeks post-infusion. *************************************************************** Adaptive Biotechnologies does not provide raw data. ***************************************************************