Active Not RecruitingPhase 1NCT04044859

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

StatusActive Not Recruiting
PhasePhase 1
U.S. locations17
SponsorUSWM CT, LLC
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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