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Genetically modified immune cells take on eight cancer types in early trial

NCT ID NCT04044859

Disease control Sponsor: USWM CT, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This early-stage trial tests a personalized cell therapy called ADP-A2M4CD8 in people with certain cancers that have a specific marker (MAGE-A4). The therapy uses a patient's own immune cells, modified to better attack tumors, and is given alone or with standard immunotherapy drugs. Up to 120 adults with cancers like lung, ovarian, or melanoma are enrolled to check safety and initial signs of tumor shrinkage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ADP-A2M4CD8 T-cells (genetically modified immune cells) alone or with nivolumab or pembrolizumab
What this could lead to
If successful, this could point toward a new treatment option for several hard-to-treat cancers that express MAGE-A4.
What could go wrong
This is an early Phase 1 trial with only 120 participants, so safety and effectiveness are not yet proven. There are risks of serious side effects from the cell therapy and immune checkpoint inhibitors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2019

Expected to finish

Apr 2037

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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.

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Conditions

The condition(s) this trial relates to.

endometrial cancer endometrium neoplasm esophageal cancer Esophageal Neoplasms gastric cancer gastric neoplasm gastroesophageal junction adenocarcinoma head and neck cancer Head and Neck Neoplasms melanoma Neoplasm Metastasis non-small cell lung carcinoma ovarian cancer urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endometrial cancer Esophageal cancer Esophagogastric junction (EGJ) Gastric (stomach) cancer Head and neck cancer Melanoma Non-small cell lung (NSCLC) Ovarian cancer Urothelial cancer

Contacts and locations

Locations

  • Clinica Universitaria de Navarra

    Pío, Pamplona, 31008, Spain

  • Duke University Medical Center, Duke Cancer Institute

    Durham, North Carolina, 27710, United States

  • Froedtert Hospital and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Hospital Clinico de Valencia

    Ibanez, Valencia, 46010, Spain

  • Hospital Universitario 12 De Octubre

    Madrid, Avenida de Cordoba S/n, 28041, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Hospital Universitario HM Sanchinarro CIOCC

    Madrid, 28050, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • M.D. Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Name of Institution: Orlando Health Cancer Institute

    Orlando, Florida, 32806, United States

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104, United States

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Washington University - School of Medicine

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.