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Engineered immune cells take aim at multiple cancers in early trial

NCT ID NCT03132922

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early-phase study tests a personalized cell therapy for people with certain cancers (bladder, melanoma, head/neck, ovarian, lung, esophageal, stomach, or sarcoma) whose tumors have a specific marker called MAGE-A4. The treatment involves taking a patient's own immune cells, engineering them to better recognize and attack the cancer, and infusing them back. The main goals are to check safety and see if the therapy shrinks tumors.

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

71 people

The number who actually took part.

Started

May 2017

Expected to finish

Sep 2032

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.

Inclusion Criteria: 1. Subject is ≥18 to 75 years of age at the time of signing the study informed consent. 2. Subject has histologically confirmed diagnosis of any one of the indicated tumor types 3. Subject is HLA-A\*02 positive. (This determination will be made under screening protocol ADP-0000-001). 4. Subject's tumor shows expression of the MAGE-A4 RNA or protein. (This determination will be made under screening protocol ADP-0000-001). 5. Adequate organ function as indicated in the study protocol 6. Subject has measurable disease according to RECIST v1.1 criteria prior to lymphodepletion 7. Subject meets disease-specific requirements per protocol 7\. Subject has anticipated life expectancy \> 6 months prior to leukapheresis and \>3 months prior to lymphodepletion. Exclusion Criteria: 1. Subject does not express appropriate HLA-A genotype 2. Subject is receiving excluded therapy/treatment per protocol 3. Subject has symptomatic CNS metastases. 4. Subject has any other active malignancy besides the tumor under study within 3 years prior to Screening. Subject has uncontrolled intercurrent illness. 5. Subject has active infection with HIV, HBV, HCV or HTLV 6. Subject is pregnant or breastfeeding. Additional Exclusion Criteria for the Radiation Substudy: * Subject does not meet eligibility criteria for the main study (ADP-0044-001). * Subject does not have at least one target lesion amenable to radiation. * Certain radiation therapy within 6 months of clinical trial are an exclusion. * Metastatic disease impinging on the spinal cord or threatening spinal cord compression.

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Conditions

The condition(s) this trial relates to.

adenocarcinoma esophageal cancer Esophageal Neoplasms gastric cancer gastric neoplasm gastroesophageal junction adenocarcinoma head and neck cancer Head and Neck Neoplasms melanoma myxoid liposarcoma myxoid/round cell liposarcoma Neoplasm Metastasis non-small cell lung carcinoma ovarian cancer sarcoma synovial sarcoma urinary bladder cancer Urinary Bladder Neoplasms

As listed by the trial registrant

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

Esophageal cancer Gastric cancer Gastroesophageal junction Head and neck cancer Melanoma Myxoid/round cell liposarcoma Non-small cell lung cancer Ovarian cancer Synovial sarcoma Urinary bladder cancer

Contacts and locations

Locations

  • Duke University Medical Center, Duke Cancer Institute

    Durham, North Carolina, 27710, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • M.D. Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G1X6, Canada

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

  • Tennessee Oncology - Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • Washington University

    St Louis, Missouri, 63112, 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.