drugset / Trial / NCT07553390

Phase 1b Study Of TRICK-NK In Combination With T-Dxd In Treatment-Refractory Breast Cancers

NCT07553390

Phase 1 Not yet recruiting 60 enrolled M.D. Anderson Cancer Center
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to find the highest tolerable dose of TGFBR-2 KO CD70 CAR NK (TRICK-NK) in combination with 2 doses of T-Dxd that can be given to participants who have advanced breast cancer. The safety of TRICK-NK will also be studied. The goal of Part 1 (dose escalation) of this clinical research study is to find the highest tolerable dose of TRICK-NK (in combination with T-Dxd) that can be given to participants who have advanced breast cancer. The goal of Part 2 (dose expansion) of this clinical research study is to learn if the dose of TRICK-NK found in Part 1 can help to control the disease. The optional schedule optimization phase will test a shorter interval between the NK cell infusion and the first dose of T-Dxd.

Timeline

Start
2026-10-01
Primary completion
2036-03-30
Completion
2038-03-30

Drugs

EvaluationDrugModalityDoseRoute
Subject TGFBR2 KO iC9/TROP2.CAR/IL-15 NK cells Cell therapy Intravenous
Subject Trastuzumab deruxtecan Monoclonal antibody Intravenous
Background Rimiducid Other / unclassified Intravenous

Indications