ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)
NCT ID: NCT04044859
Last Updated: 2025-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
120 participants
INTERVENTIONAL
2019-08-20
2037-04-30
Brief Summary
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Detailed Description
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Endometrial Esophageal Cancer Esophagogastric Junction (EGJ) Gastric (stomach) Head and Neck Melanoma Non-small Cell Lung (NSCLC) Ovarian Cancer
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Autologous genetically modified ADP-A2M4CD8 cells
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Subject is positive for at least 1 HLA-A\*02 inclusion allele
* Histologically or cytogenetically confirmed diagnosis of urothelial cancer, esophageal, esophagogastric junction (EGJ) cancer, gastric cancer, non-small cell lung carcinoma (NSCLC), head and neck or ovarian cancer, endometrial cancer, melanoma
* Measurable disease according to RECIST v1.1 prior to leukapheresis and lymphodepletion.
* Tumor shows MAGE-A4 expression as confirmed by central laboratory
* ECOG Performance Status of 0 or 1.
Exclusion Criteria
* Positive for any HLA-A\*02 allele other than: one of the inclusion alleles
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study
* Active autoimmune or immune mediated disease
* Leptomeningeal disease, carcinomatous meningitis or symptomatic CNS metastases
* Other prior malignancy that is not considered by the Investigator to be in complete remission. Clinically significant cardiovascular disease
* Uncontrolled intercurrent illness
* Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus
* Pregnant or breastfeeding
18 Years
75 Years
ALL
No
Sponsors
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Adaptimmune
INDUSTRY
ICON plc
INDUSTRY
Responsible Party
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Principal Investigators
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David Hong, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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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
Countries
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Other Identifiers
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ADP-0055-001
Identifier Type: -
Identifier Source: org_study_id
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