ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)
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.
Checked against the public recordLast updated Aug 12, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- USWM CT, LLC
- Interventions being studied
- Genetic: Autologous genetically modified ADP-A2M4CD8 cells alone or in combination with nivolumab every four weeks or pembrolizumab every 6 weeks
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
* 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Name of Institution: Orlando Health Cancer InstituteOrlando, Florida
- Massachusetts General HospitalBoston, Massachusetts
- Washington University - School of MedicineSt Louis, Missouri
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Duke University Medical Center, Duke Cancer InstituteDurham, North Carolina
- OU Health Stephenson Cancer CenterOklahoma City, Oklahoma
- Sarah Cannon Research InstituteNashville, Tennessee
- M.D. Anderson Cancer CenterHouston, Texas
- Froedtert Hospital and the Medical College of WisconsinMilwaukee, Wisconsin
- Princess Margaret Cancer CentreToronto, Ontario
- Hospital Universitario 12 De OctubreMadrid, Avenida de Cordoba S/n
- Clinica Universitaria de NavarraPío, Pamplona
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 12, 2026. Always confirm current availability with the study team.