Spots Global Cancer Trial Database for 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

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Trial Identification

Brief Title: 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

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

Study ID: NCT05672459

Conditions

Solid Tumor

Interventions

Single Injection of IVS-3001- Anti - HLA-G CAR-T cells

Fludarabine phosphate

Cyclophosphamide

leukapheresis

Study Description

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