Ovarian Cancer Clinical Trial
ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)
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.
Full Description
Conditions:
Endometrial Esophageal Cancer Esophagogastric Junction (EGJ) Gastric (stomach) Head and Neck Melanoma Non-small Cell Lung (NSCLC) Ovarian Cancer
Eligibility 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, 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.
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
Subjects must have ≥ 90% room air oxygen saturation at rest at Screening (within 7 days of leukapheresis) and at Baseline.
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.
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There are 19 Locations for this study
Orlando Florida, 32806, United States More Info
Principal Investigator
Boston Massachusetts, 02114, United States More Info
Principal Investigator
Saint Louis Missouri, 63110, United States More Info
Principal Investigator
Buffalo New York, 14040, United States
New York New York, 10065, United States More Info
Principal Investigator
Durham North Carolina, 27710, United States More Info
Principal Investigator
Oklahoma City Oklahoma, 73104, United States More Info
Principal Investigator
Philadelphia Pennsylvania, 19107, United States
Nashville Tennessee, 37203, United States More Info
Principal Investigator
Houston Texas, 77030, United States More Info
Principal Investigator
Milwaukee Wisconsin, 53226, United States More Info
Principal Investigator
Bruxelles , , Belgium
Edegem , , Belgium
Gent , , Belgium
Toronto Ontario, M5G 2, Canada More Info
Principal Investigator
Madrid Avenida De Cordoba S/n, 28041, Spain More Info
Principal Investigator
Pio Pamplona, 31008, Spain More Info
Principal Investigator
Ibanez Valencia, 46010, Spain More Info
Principal Investigator
Barcelona , 08035, Spain More Info
Principal Investigator
Madrid , 28040, Spain More Info
Principal Investigator
Madrid , 28050, Spain More Info
Principal Investigator
Sevilla , 41013, Spain More Info
Principal Investigator
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