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ACTIVE NOT RECRUITING Phase 1

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

NCT04044859 · View on ClinicalTrials.gov ↗

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.

Interventions

  • GENETIC Autologous genetically modified ADP-A2M4CD8 cells alone or in combination with nivolumab every four weeks or pembrolizumab every 6 weeks

Study Locations (17)

Other

  • Hospital Universitario Vall d'Hebron — Barcelona
  • Hospital Universitario Fundacion Jimenez Diaz — Madrid
  • Hospital Universitario HM Sanchinarro CIOCC — Madrid
  • Hospital Universitario Virgen del Rocio — Seville

Florida

  • Name of Institution: Orlando Health Cancer Institute — Orlando

Massachusetts

  • Massachusetts General Hospital — Boston

Missouri

  • Washington University - School of Medicine — St Louis

New York

  • Memorial Sloan Kettering Cancer Center — New York

North Carolina

  • Duke University Medical Center, Duke Cancer Institute — Durham

Oklahoma

  • OU Health Stephenson Cancer Center — Oklahoma City

Tennessee

  • Sarah Cannon Research Institute — Nashville

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2019-08-20
Est. Completion 2037-04-30
Phase Phase 1

Sponsor

USWM CT

7 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04044859

The ClinicalTrials.gov registry entry for NCT04044859 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is USWM CT, which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 9 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 1 intervention — of which Autologous genetically modified ADP-A2M4CD8 cells alone or in combination with nivolumab every four weeks or pembrolizumab every 6 weeks is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04044859 reports 17 study locations spanning 14 distinct geographic areas — top geographies include Other, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04044859 about?

NCT04044859 is a clinical study titled "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...

What is the current status of trial NCT04044859?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2019-08-20. Estimated completion is 2037-04-30.

What conditions does trial NCT04044859 study?

This clinical trial studies the following conditions: Ovarian Cancer, Melanoma, Head and Neck Cancer, Endometrial Cancer, Esophageal Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04044859?

The interventions under investigation include: Autologous genetically modified ADP-A2M4CD8 cells alone or in combination with nivolumab every four weeks or pembrolizumab every 6 weeks (GENETIC). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04044859?

This trial is sponsored by USWM CT, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04044859 being conducted?

This trial has 17 study locations across Florida, Massachusetts, Missouri, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial