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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 23, 2026 · Source: ClinicalTrials.gov
The study is underway but is not accepting new participants.
Interventional
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Key
- 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/
- may apply
- Subjects must have ≥ 90% room air oxygen saturation at rest at Screening (within 7 days of leukapheresis) and at Baseline. Key
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: Sep 23, 2026. Always confirm current availability with the study team.