Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT05672459
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
Study:
NCT05672459
Study Brief:
Protocol Section:
NCT05672459