Primary Objectives:~IVS-3001 is an autologous CAR-T cell therapy targeting human leukocyte antigen (HLA-G)~Phase 1: To determine the safety, tolerability and the recommended phase 2 dose (RP2D) of IVS-3001 in subjects with refractory or relapsed HLA-G+ solid tumors.~Phase 2a: To evaluate the anti-tumor activity of IVS-3001 in selected HLA-G+ solid tumor types.~Secondary Objectives:~To evaluate pharmacokinetic profile of IVS-3001: persistence, expansion.~To evaluate the clinical activity of IVS-3001 in selected HLA-G+ solid tumor types.~To assess the long-term safety of IVS-3001.~Exploratory Objectives:~• To explore functionality of IVS-3001 as well as immune biomarkers linked with IVS-3001 and their relationship with clinical response
The proposed clinical study is a Phase 1/2a trial to investigate the safety, tolerability, pharmacokinetics and clinical activity of anti-HLA-G CAR-T cells IVS-3001 administered to subjects with previously treated, locally advanced, or metastatic solid tumors which are HLA-G positive (HLA-G+) - as determined by immunohistochemistry (IHC) analysis on tumor biopsies using the 4H84 antibody.