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ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)
Sponsor: USWM CT, LLC
Summary
This study will investigate the safety and tolerability of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and MAGE-A4 tumor antigen. Tumor indications include endometrial, esophageal, esophagogastric junction (EGJ), gastric, head and neck, melanoma, non-small cell lung (NSCLC), ovarian or urothelial cancer.
Official title: A Phase 1 Dose Escalation Study To Assess Safety And Efficacy Of ADP-A2M4CD8 As Monotherapy Or In Combination With Either Nivolumab Or Pembrolizumab In HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2019-08-20
Completion Date
2037-04-30
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
Autologous genetically modified ADP-A2M4CD8 cells alone or in combination with nivolumab every four weeks or pembrolizumab every 6 weeks
Infusion of autologous genetically modified ADP-A2M4CD8 on Day 1 alone or in combination with either nivolumab 480 mg IV every four weeks or pembrolizumab 400mg IV every 6 weeks
Locations (17)
Name of Institution: Orlando Health Cancer Institute
Orlando, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University - School of Medicine
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University Medical Center, Duke Cancer Institute
Durham, North Carolina, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
M.D. Anderson Cancer Center
Houston, Texas, United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Hospital Universitario 12 De Octubre
Madrid, Avenida de Cordoba S/n, Spain
Clinica Universitaria de Navarra
Pío, Pamplona, Spain
Hospital Clinico de Valencia
Ibanez, Valencia, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Hospital Universitario HM Sanchinarro CIOCC
Madrid, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain