Phase 1b Study Of Allogeneic CAR TROP2/IL15 Transduced TGFBR2 KO CB NK-Cells (TRICK-NK) In Combination With Trastuzumab Deruxtecan (T-Dxd) In Treatment-Refractory Breast Cancers
M.D. Anderson Cancer Center
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.
Description
Primary Objective: To determine the safety, tolerability, maximum tolerated dose (MTD) and administration schedule, and optimal cell dose (OCD) and schedule of CAR.TROP2/IL15-transduced / TGFBR2KO CB-NK cells \[TRICK-NK - TROP2-targeted, Reprogrammed with IL-15, CBderived, Knockout (TGFBR2) NK\] + T-Dxd, in T-Dxd eligible HER2 positive and HER2 low advanced breast cancers. Secondary Objectives: To determine the antitumor activity of TRICK-NK + T-Dxd combination The intent of offering this treatment is to provide a possible therapeutic benefit and thus, the patient will be carefully monitor…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients must have histologically confirmed breast cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. 2. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for nonnodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. 3. Age ≥18 years. Because no dosing or adverse event data are cur…
Interventions
- DrugTGFBR2 KO iC9/TROP2.CAR/IL-15 NK cells
Given by IV
- DrugTrastuzumab deruxtecan (T-DXd)
Given by IV
- DrugRimiducid
Given by IV
Location
- UT MD AndersonHouston, Texas