This is a Phase 1, open-label, multi-center study to assess safety and determine the recommended phase 2 dose (RP2D) of ACTR T cell product (ACTR707 or ACTR087) in combination with trastuzumab, following lymphodepleting chemotherapy in subjects with HER2-positive advanced malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Autologous Antibody-Coupled T Cell Receptor (ACTR) T Cell Product (ACTR707 or ACTR087)
monoclonal antibody targeting HER2
Yale Smilow Cancer Hospital
New Haven, Connecticut, United States
Miami University Cancer Center
Miami, Florida, United States
The Ohio State University
Columbus, Ohio, United States
Sarah Cannon Research Institute/Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Safety and tolerability of ACTR T cell product with trastuzumab as assessed by committee review of dose limiting toxicities (DLTs), incidence and severity of adverse events (AEs) and clinically significant abnormalities of laboratory values
Time frame: 42 days
Determination of recommended phase 2 dose (RP2D) regimen
Review of DLTs, maximum tolerated dose (MTD), incidence and severity of AEs and clinically significant abnormalities of laboratory values
Time frame: 42 days
Anti-tumor activity as measured by overall response rate (ORR) per iRECIST
Time frame: 52 weeks
Anti-tumor activity as measured best overall response (BOR)
Time frame: 52 weeks
Anti-tumor activity as measured by duration of response (DOR)
Time frame: 52 weeks
Anti-tumor activity as measured by progression-free survival (PFS)
Time frame: 52 weeks
Anti-tumor activity as measured by overall survival (OS)
Time frame: 52 weeks
Assessment of persistence of ACTR as measured by flow cytometry
Time frame: 52 weeks
Assessment of persistence of ACTR as measured by quantitative polymerase chain reaction (qPCR)
Time frame: 52 weeks
Assessment of ACTR phenotype and function as measured by flow cytometry
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Baylor Scott & White Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Time frame: 52 weeks
Assessment of induction of inflammatory markers and cytokines/chemokines after ACTR T cell product administration
Levels of inflammatory markers, cytokines/chemokines in blood
Time frame: 52 weeks
Trastuzumab pharmacokinetics (PK)
trastuzumab serum concentration, Area Under the Curve (AUC), trough levels
Time frame: 52 weeks