Active Not RecruitingPhase 1NCT04044859
Official study title

ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAutologous genetically modified ADP-A2M4CD8 cells alone or in combination with nivolumab every four weeks or pembrolizumab every 6 weeks

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 23, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 1

Interventional

Where is it offered?17 U.S. locations

Locations may change over time.

Who runs it?USWM CT, LLC

Study sponsor

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

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.

Requirements people may need to meetInclusion criteria
  • 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/
Reasons someone may not be able to joinExclusion criteria
  • 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.

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: Sep 23, 2026. Always confirm current availability with the study team.

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