Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-25 @ 5:57 PM
Study NCT ID:
NCT05672459
Status:
RECRUITING
Last Update Posted:
2025-08-14
First Post:
2023-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2023-00020 | OTHER | NCI-CTRP Clinical Trials Registry | View |