A Safety And Efficacy Study Of HLA-G- Targeted CAR-T Cells IVS-3001 In Subjects With Previously Treated Advanced HLA-G-Positive Solid Tumors
brief summary
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.
detailed description
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
official title
A Phase 1/2a, Safety And Efficacy Study Of HLA-G- Targeted CAR-T Cells IVS-3001 In Subjects With Previously Treated Advanced HLA-G-Positive Solid Tumors