This is a phase 1, multi-center, single-arm, open-label study evaluating the safety, tolerability, and anti-myeloma activity of ACTR087 (an autologous T cell product) in combination with SEA-BCMA (a monoclonal antibody) in subjects with relapsed or refractory Multiple Myeloma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Mayo Clinic
Phoenix, Arizona, United States
Mayo Clinic
Jacksonville, Florida, United States
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Safety and tolerability of ACTR087 in combination with SEA-BCMA
Composite outcome measure assessed by committee review of dose limiting toxicities (DLTs), incidence and severity of AEs and clinically significant abnormalities of laboratory values
Time frame: 28 days
Determination of recommended Phase 2 dosing regimen
Review of DLTs, Maximum tolerated contour (MTC), incidence and severity of AEs and clinically significant abnormalities of laboratory values
Time frame: 52 weeks
Safety of SEA-BCMA as measured by incidence of Treatment Emergent Adverse Events (TEAEs)
Review of all TEAEs, including incidence and severity of AEs, DLTs and clinically significant abnormalities of laboratory values
Time frame: 21 days
Anti-myeloma activity as measured by overall response rate (per IMWG response criteria)
Time frame: 52 weeks
Anti-myeloma activity as measured by duration of response
Time frame: 52 weeks
Anti-myeloma activity as measured by progression-free survival
Time frame: 52 weeks
Anti-myeloma activity as measured by overall survival
Time frame: 52 weeks
Assessment of persistence of ACTR087 as measured by flow cytometry and qPCR
Time frame: 52 weeks
Assessment of ACTR087 phenotype and function as measured by flow cytometry
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Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Baylor Scott & White
Dallas, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Time frame: 52 weeks
Assessment of induction of inflammatory markers and cytokines/chemokines after ACTR087 administration
Levels of inflammatory markers, cytokines/chemokines
Time frame: 52 weeks
SEA-BCMA PK
SEA-BCMA plasma concentration
Time frame: 52 weeks
Assessment of anti-drug antibodies (ADA) after SEA-BCMA administration
Incidence of ADAs to SEA-BCMA
Time frame: 52 weeks