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Surpass: ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Tumors

Trial Status: Active

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 tumor antigen status and whose synovial sarcoma, myxoid / round cell liposarcoma (MRCLS), melanoma, urothelial, head and neck, ovarian, gastric (stomach), esophagogastric junction (EGJ), non-small cell lung (NSCLC), or esophageal cancer that express the MAGE-A4 protein.

Inclusion Criteria

  • - Key Inclusion criteria - Age ≥18 and ≤ 75 years - Subject is positive for at least 1 HLA-A*02 inclusion allele - Histologically or cytogenetically confirmed diagnosis of urothelial cancer, melanoma, ovarian cancer, esophageal , esophagogastric junction (EGJ) cancer, gastric cancer, non-small cell lung carcinoma (NSCLC), head and neck, synovial sarcoma or myxoid/round cell liposarcoma (MRCLS) - Measurable disease according to RECIST v1.1 prior to leukapheresis and lymphodepletionHLA-A*02 positive. - Tumor shows MAGE-A4 expression as confirmed by central laboratory - ECOG Performance Status of 0 or 1. - Left ventricular ejection fraction (LVEF) ≥50% or the institutional lower limit of normal range, whichever is lower Note: other protocol defined Inclusion/Exclusion criteria may apply Key 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 Note: other protocol defined Inclusion/Exclusion criteria may apply.

Kansas

Kansas City
University of Kansas Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Massachusetts

Boston
Massachusetts General Hospital Cancer Center
Status: ACTIVE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

New York

Buffalo
Roswell Park Cancer Institute
Status: ACTIVE

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE
Contact: Danxia Ke
Phone: 713-792-4384

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Adaptimmune Limited

  • Primary ID ADP-0055-001
  • Secondary IDs NCI-2019-05548
  • Clinicaltrials.gov ID NCT04044859