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drugset / Trial / 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

NCT05672459 ↗

Phase 1/2 Active not recruiting 31 enrolled M.D. Anderson Cancer Center Invectys · collab
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-06-21
Primary completion
2028-06-29
Completion
2028-12-29

Drugs

EvaluationDrugModalityDoseRoute
Subject IVS-3001 Cell therapy — Intravenous
Background Cyclophosphamide Other / unclassified — Intravenous
Background Fludarabine Small molecule — Intravenous

Indications

neoplasm