Phase 1b Study Of TRICK-NK In Combination With T-Dxd In Treatment-Refractory Breast Cancers
NCT07553390 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-04-28
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.
Conditions
Interventions
- DRUG
-
TGFBR2 KO iC9/TROP2.CAR/IL-15 NK cells
Given by IV
- DRUG
-
Trastuzumab deruxtecan (T-DXd)
Given by IV
- DRUG
-
Rimiducid
Given by IV
Sponsors & Collaborators
-
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Bora Lim, MD · UT MD Anderson
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-10-01
- Primary Completion
- 2036-03-30
- Completion
- 2038-03-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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