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
More Related Trials
-
T-DXd in the First-Line Treatment of Locally Advanced or Metastatic TNBC-LAR HER2-low Patients
NCT05953168 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Trial of Trastuzumab Deruxtecan in Previously Treated HER2
NCT06750484 ·Status: RECRUITING ·Phase: PHASE2
-
TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd
NCT06533826 ·Status: RECRUITING ·Phase: PHASE2
-
Docetaxel, Carboplatin, and Trastuzumab and/or Lapatinib in Treating Women With Stage I, Stage II, or Stage III Breast Cancer That Can Be Removed by Surgery
NCT00769470 ·Status: COMPLETED ·Phase: PHASE2
-
Trastuzumab, Ixabepilone, and Carboplatin in Treating Patients With HER2/Neu-Positive Metastatic Breast Cancer
NCT00077376 ·Status: COMPLETED ·Phase: PHASE2
-
Pertuzumab, Trastuzumab, and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With HER2-Positive Advanced Breast Cancer
NCT01730833 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Trastuzumab and Pertuzumab in Treating Patients With Unresectable Locally Advanced or Metastatic Breast Cancer That Did Not Respond to Previous Trastuzumab
NCT00301899 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Preliminary Efficacy of SNK01 in Combination With Trastuzumab or Cetuximab in Subjects With Advanced HER2 or EGFR Cancers
NCT04464967 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
Trastuzumab and RAD001 in Patients With Human Epidermal Growth Receptor 2 (HER-2) Overexpressing Breast Cancer
NCT00317720 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer
NCT04553770 ·Status: RECRUITING ·Phase: PHASE2
-
Phase 1b/2 Study of BKM120 Plus Trastuzumab in Patients With HER2-positive Breast Cancer
NCT01132664 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Trastuzumab in Combination With AMG 479 in HER-2 Overexpressing MBC Progressing on Trastuzumab
NCT01479179 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer
NCT04539938 ·Status: COMPLETED ·Phase: PHASE2
-
Trastuzumab Plus R115777 in Treating Patients With Advanced or Metastatic Cancer
NCT00005842 ·Status: COMPLETED ·Phase: PHASE1
-
Trastuzumab, Docetaxel, and Carboplatin in Treating Women With Stage II, Stage III, or Inflammatory Breast Cancer
NCT00118053 ·Status: TERMINATED ·Phase: PHASE2
-
A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer
NCT06585969 ·Status: WITHDRAWN ·Phase: PHASE3
-
Trastuzumab and Interleukin-2 in Treating Patients With Metastatic Breast Cancer
NCT00006228 ·Status: COMPLETED ·Phase: PHASE2
-
1303GCC: Trastuzmab & Pertuzumab With Hormonal Therapy or Chemotherapy in Women Aged 60 and Over.
NCT02000596 ·Status: TERMINATED ·Phase: PHASE2
-
Trastuzumab Deruxtecan in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management
NCT07371585 ·Status: RECRUITING ·Phase: PHASE2
-
T-DXd With or Without Bevacizumab for HER2-low Breast Cancer With Brain Metastasis
NCT07150208 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Chimeric Receptor T Cells With Trastuzumab in HER2+ Advanced Breast Cancer and Other Solid Tumors
NCT06027983 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2
-
Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab
NCT05744375 ·Status: TERMINATED ·Phase: PHASE2
-
TRUDI: TDXD+Durva in HER2+/Low IBC
NCT05795101 ·Status: RECRUITING ·Phase: PHASE2
-
Akt Inhibitor MK2206, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With Locally Advanced or Metastatic HER2-Positive Breast , Gastric, or Gastroesophageal Cancer That Cannot Be Removed By Surgery
NCT01705340 ·Status: TERMINATED ·Phase: PHASE1
-
Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2
NCT00004883 ·Status: COMPLETED ·Phase: PHASE2