NCT05672459

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

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Single Injection of IVS-3001- Anti - HLA-G CAR-T cells	Given by IV (vein)
DRUG	Fludarabine phosphate	Given by IV (vein)
DRUG	Cyclophosphamide	Given by IV (vein)
PROCEDURE	leukapheresis	Given by IV (vein)

Timeline

• Start date: 2023-06-21
• Primary completion: 2026-06-29
• Completion: 2029-12-29
• First posted: 2023-01-05
• Last updated: 2026-02-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study