The purpose of the UNIVERSAL study is to assess the safety, efficacy, cell kinetics, and immunogenicity of ALLO-715 with or without Nirogacestat in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen of ALLO-647 in combination with fludarabine and/or cyclophosphamide, or ALLO-647 alone.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
132
ALLO-715 is an allogeneic CAR T cell therapy targeting BCMA
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
Chemotherapy for lymphodepletion
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
City of Hope
Duarte, California, United States
Stanford Cancer Institute
Palo Alto, California, United States
Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-715
Dose limiting toxicities are defined as ALLO-715-related adverse events with onset within 28 days following infusion of ALLO-715.
Time frame: 28 Days
To assess the overall safety profile and tolerability of ALLO-647 in combination with Fludarabine and/or cyclophosphamide or ALLO-647 alone, prior to ALLO-715 to confirm the dose of ALLO-647.
The proportion of subjects in a dose cohort with DLTs of ALLO-647
Time frame: 33 days
To assess the overall safety profile and tolerability of nirogacestat given concomitantly with ALLO-715 following lymphodepletion with Flu/ Cy/ ALLO-647.
Dose limiting toxicities are defined as ALLO-715-related adverse events with onset within 28 days following infusion of ALLO-715.
Time frame: 28 days
Cellular kinetics of ALLO-715
Levels of anti-BCMA CAR T cells in blood
Time frame: up to 60 months
antitumor activity of ALLO-715 in combination with nirogacestat
overall -response rate (ORR)
Time frame: up to 60 months
Cellular kinetics of ALLO-715 in combination with nirogacestat
Levels of anti-BCMA CAR T cells in blood
Time frame: up to 60 months
Pharmacokinetics of ALLO-647
Serum concentration levels of ALLO-647
Time frame: up to 60 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Chemotherapy for lymphodepletion
a small molecule, selective, reversible, noncompetitive inhibitor of γsecretase (GSI) that increases BCMA target density on the surface of multiple myeloma cells.
Sarah Cannon/Colorado Blood Cancer Institute
Denver, Colorado, United States
Mayo Clinic
Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
St. David's South Austin Medical Center
Austin, Texas, United States
Texas Transplant Institute
San Antonio, Texas, United States
...and 1 more locations
Pharmacokinetics of nirogacestat
Serum concentration levels of nirogacestat
Time frame: up to 60 months
Incidence of immunogenicity against ALLO-715 and ALLO-647
detection and levels of anti-drug antibodies
Time frame: up to 60 months
Immune monitoring after lymphodepletion regimen
Detection of the following circulating cells: T cell subset, B lymphocytes, and NK cells
Time frame: up to 60 months
Anti-tumor activity of ALLO-715
overall response rate
Time frame: up to 60 months
Anti-tumor activity of ALLO-715
duration of response
Time frame: up to 60 months
Anti-tumor activity of ALLO-715
overall survival
Time frame: up to 60 months
Anti-tumor activity of ALLO-715
minimal residual disease
Time frame: up to 60 months
To evaluate the expression of BCMA in bone marrow plasma cells with and without nirogacestat
Overall response rate of ALLO-715 with and without Nirogacestat
Time frame: up to 60 months