404
Participants
Start Date
December 5, 2023
Primary Completion Date
January 31, 2026
Study Completion Date
June 30, 2026
SV-BR-1-GM
SV-BR-1-GM is an experimental, allogeneic, whole cell breast tumor cell line stably transfected with the CSF2 gene (encoding GM-CSF) to secrete GM-CSF in vivo to consequently augment dendritic cell activity
Cyclophosphamide
Cyclophosphamide is an alkylating agent with indications for treatment of malignant diseases including breast cancer. Cyclophosphamide (Cytoxan) 300 mg/m2 I.V., single dose, will be given to patients assigned to the SV-BR-1-GM. Cyclophosphamide will be administered 2-3 days prior to SV-BR-1-GM inoculations.
Interferon infiltration of the inoculation site
Interferon is a cytokine released by cells to regulate immune responses to viral infections. For this study, 0.1 mcg Pegasys per injection site (x 4 injection sites) will be administered.
Retifanlimab
Retifanlimab is a checkpoint inhibitor. A total dose of 375mg will be administered at first cycle on or about day +2 (+/-1d). In all other cycles, Retifanlimab is permitted to be administered between Day -2/-3 to Day 2±1 of the cycle based on the convenience of the patients and the clinical sites. However once the timing of the CPI is chosen for C1, it must be given on the same day thereafter throughout the trial.
Treatment of Physician's Choice
Patients in the TPC arm of the study will be treated with one or a combination of the following: carboplatin, taxanes, capecitabine, gemcitabine, vinorelbine or eribulin in accordance with the investigators and institutional standard of care. For HER2+ patients, a HER2-targeted agent of the physician's choice can be part of TPC.
RECRUITING
Manhattan Hematology /Oncology Associates, New York
RECRUITING
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C (NY), New York
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New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C (Brox), The Bronx
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New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C.(New Hyde Park), New Hyde Park
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New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Babylon), Babylon
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New York Cancers & Blood Specialists_North Shore Hematology Oncology Assocaites P.C (Patchogue), Patchogue
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New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Port Jefferson Station2), Port Jefferson Station
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New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C.(Port Jefferson Station1), Port Jefferson Station
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New York Cancers & Blood Specialists, Port Jefferson Station
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New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Riverhead), Riverhead
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The Center for Cancer and Blood Disorders a division of American Oncology Partners, P.A., Bethesda
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Hematology-Oncology Associates of Fredericksburg, Inc, Fredericksburg
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Winship Cancer Institute of Emory University, Atlanta
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Mayo Clinic Florida-Comprehensive Cancer Center, Jacksonville
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Advent Health - Orlando, Orlando
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University of Miami_SCCC-Hollywood, Hollywood
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University of Miami_SCCC-Coral Springs, Coral Springs
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University Of Miami-SCCC-Miami, Miami
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University of Miami-SCCC-Lennar, Coral Gables
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University of Miami_SCCC - Kendall, Miami
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University of Miami _SCCC - Aventura, Aventura
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University of Miami-SCCC-Plantation, Plantation
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University of Miami Hospital and Clinics - Deerfield Beach, Deerfield Beach
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Cleveland Clinic, Cleveland
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Gabrail Cancer & Research Center, Canton
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Northwest Cancer Center, Dyer
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Sheboygan Cancer & Blood Specialists, Sheboygan
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Mayo Clinic-Comprehensive Cancer Center-Breast Clinic, Rochester
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Northwestern University, Chicago
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Carle Foundation Cancer Institute-Urbana, Urbana
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Southern Illinois University-Simmons, Springfield
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AMR Kansas City Oncology, Kansas City
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Nebraska Cancer Specialists, Omaha
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Care Access-Marrero, Marrero
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Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas
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Mary Crowley Cancer Research, Dallas
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Tranquil Clinical Research, Webster
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Texas Oncology, New Braunfels, New Braunfels
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Texas Oncology-San Antonio Cancer Care, San Antonio
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Texas Oncology - San Antonio Northeast, San Antonio
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Texas Oncology - San Antonio Stone Oak, San Antonio
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Texas Oncology McAllen, McAllen
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DHR Health Oncology Institute, Edinburg
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Texas Oncology - Harlingen, Harlingen
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Texas Oncology - Weslaco, Weslaco
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Texas Oncology - Fredericksburg, Fredericksburg
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Mayo Clinic-Comprehensive Cancer Center-Breast Clinic, Phoenix
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University of Arizona-Cancer Center, Tucson
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Los Angeles Cancer Network, Los Angeles
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Cedars-Sinai Cancer at Cedars-Sinai Medical Facility, Los Angeles
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Cedars-Sinai Breast Health Services Building, West Hollywood
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Los Angeles Cancer Network_Century City, Los Angeles
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UCLA-Hematology/Oncology Medical Plaza, Los Angeles
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UCLA-Hematology/Oncology_LA 2, Los Angeles
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UCLA-Hematology/Oncology_LA, Los Angeles
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Cedars-Sinai Cancer Beverly Hills, Beverly Hills
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St. John's Cancer Center, Santa Monica
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UCLA-Department of Medicine Hematology/Oncology-Parkside, Santa Monica
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UCLA-Hetamtology/Oncology_S Monica, Santa Monica
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Torrance Memorial Cancer Center, Torrance
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Los Angeles Cancer Network_Pasadena, Pasadena
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Los Angeles Cancer Network_Glendale, Glendale
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Los Angeles Cancer Network_Valley Pres, Van Nuys
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UC San Diego, San Diego
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Los Angeles cancer Network_Riverside, Riverside
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Hoag Hospital Center, Irvine
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Hoag Hospital Irvine, Irvine
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Los Angeles cancer Network_Fountain Vallley, Fountain Valley
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Los Angeles cancer Network_Anaheim, Anaheim
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Los Angeles Cancer Network_Corona, Corona
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Comprehensive Blood and Cancer Center, Bakersfield
RECRUITING
Cancer Care Northwest-1 (601 S. Sherman), Spokane
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Cancer Care Northwest_2 (605 E. Holland), Spokane
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Cancer Care Northwest, Spokane Valley
RECRUITING
Smilow Cancer Hospital at Yale New Haven, New Haven
RECRUITING
Dartmouth Hitchcock Medical Center, Lebanon
RECRUITING
Hunterdon Medical Center, Flemington
Lead Sponsor
BriaCell Therapeutics Corporation
INDUSTRY