MAC001 / Macera Therap - LARVOL DELTA

A phase 1, first-in-human study of autologous monocytes engineered to express an anti-HER2 chimeric antigen receptor (CAR) in participants with HER2-overexpressing solid tumors. (ASCO 2024) - P1 | "The anti-HER2 CAR-M cell therapy product, CT-0508, is currently being evaluated in a Phase I trial as a monotherapy and in combination with pembrolizumab...Filgrastim mobilized autologous CD14+ monocytes are collected by apheresis, followed by manufacturing and cryopreservation...CT-0525 will be administered without conditioning chemotherapy. Primary endpoints include assessment of safety and tolerability, as well as manufacture feasibility. Correlative assessments include pre- and post-treatment biopsies and blood samples for safety, immunogenicity, pharmacokinetics, tumor trafficking, TME modulation, epitope spreading, and other translational biomarkers."

P1 data • Oncology • Solid Tumor • CD14

Human HER2-targeted Macrophages Therapy for HER2-positive Advanced Gastric Cancer With Peritoneal Metastases (clinicaltrials.gov) - P1 | N=9 | Not yet recruiting | Sponsor: First People's Hospital of Hangzhou

Metastases • New P1 trial • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor