drugset
drugset / Trial / NCT06598371

A Phase 1/2 Study of KSQ-004EX, Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate Genes Encoding SOCS1 and Regnase-1, in Patients With Select Advanced Solid Tumors

NCT06598371 ↗

Phase 1/2 Recruiting 141 enrolled M.D. Anderson Cancer Center KSQ Therapeutics, Inc. · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Phase 1 is to find the recommended dose of KSQ-004EX to give to participants with advanced solid tumors. Phase 2 is to learn if KSQ-004EX at the recommended dose found in Phase1 can help to control advanced solid tumors. The safety and effects of KSQ-004EX will also be studied in both phases.

Timeline

Start
2024-11-21
Primary completion
2039-08-01
Completion
2041-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject KSQ-004EX Cell therapy — Intravenous
Background Cyclophosphamide Other / unclassified — Intravenous
Background Fludarabine Small molecule — Intravenous
Background aldesleukin Protein / enzyme biologic — Intravenous

Indications

neoplasm