Clareo Health | ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
USWM CT, LLC
Conditions:
Endometrial Esophageal Cancer Esophagogastric Junction (EGJ) Gastric (stomach) Head and Neck Melanoma Non-small Cell Lung (NSCLC) Ovarian Cancer
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
Subjects must have ≥ 90% room air oxygen saturation at rest at Screening (within 7 days of leukapheresis) and at Baseline.
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
