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Engineered T-Cells take aim at bladder, skin, and head and neck cancers

NCT ID NCT02989064

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether genetically modified T-cells (MAGE-A10ᶜ⁷⁹⁶T) are safe for people with advanced urothelial cancer, melanoma, or head and neck cancer. Ten participants received their own engineered immune cells after chemotherapy. The main goal was to check for side effects and find the right dose, not to prove the treatment works. Researchers will follow participants for 15 years to monitor long-term effects.

What this could mean

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

Active substance
genetically modified T-cells (MAGE-A10ᶜ⁷⁹⁶T)
What this could lead to
If successful, this could lead to a new treatment option for certain hard-to-treat cancers by training the immune system to attack tumors.
What could go wrong
This is a very early Phase 1 trial with only 10 participants, so safety and effectiveness are not yet proven. The treatment may cause serious side effects or fail to shrink 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

10 people

The number who actually took part.

Started

Oct 2016

Finished

Jun 2020

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 following cancers: (A) urothelial cancer (transitional cell cancer of the bladder, ureter or renal pelvis), (B) melanoma, or (C) squamous cell carcinoma of the head and neck. 3. Subject is HLA-A\*02:01 and/or HLA-A\*02:06 positive. 4. Subject has measurable disease according to RECIST v1.1 criteria prior to lymphodepletion 5. Subject meets disease-specific requirements per protocol 6. Subject has anticipated life expectancy \> 6 months prior to leukapheresis and \>3 months prior to lymphodepletion. 7. Subject's tumor shows positive MAGE-A10 expression 8. Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. 9. Subject has a left ventricular ejection fraction ≥50%. 10. Subject is fit for leukapheresis and has adequate venous access for the cell collection. 11. Female subject of childbearing potential (FCBP) must have a negative urine or serum pregnancy test or male subject must be surgically sterile or agree to use a double barrier contraception method or abstain from heterosexual activity with a female of childbearing potential starting at the first dose of chemotherapy and for 4 months thereafter. 12. Subject must have adequate organ function per protocol Exclusion Criteria: 1. Subject is HLA-A\*02:05 in either allele, HLA-B\*15:01 and/or HLA-B\*46:01 positive. Subject has any A\*02 null allele (designated with an "N", e.g. A\*02:32N) as the sole HLA-A\*02 allele. 2. Subject has received or plans to receive excluded therapy/treatment prior to leukapheresis or lymphodepleting chemotherapy per protocol 3. Subject that has toxicity from previous anti-cancer therapy must have recovered to ≤ Grade 1 prior to enrollment 4. Subject has history of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study. 5. Subject had major surgery within 4 weeks prior to lymphodepletion; subjects should have been fully recovered from any surgical related toxicities. 6. Subject has an electrocardiogram (ECG) showing clinically significant abnormality at Screening or showing an average QTc interval ≥450 msec in males and ≥470 msec in females (≥480 msec for subjects with bundle branch block \[BBB\]) over 3 consecutive ECGs. Either Fridericia's or Bazett's formula may be used to correct the QT interval. 7. Subject has symptomatic CNS metastases. 8. Subject has a history of chronic or recurrent severe autoimmune or immune mediated disease 9. Subject has any other active malignancy besides the tumor under study within 3 years prior to Screening. 10. Subject has uncontrolled intercurrent illness 11. Subject has active infection with HIV, HBV, HCV or HTLV 12. Subject is pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Hospital Universitario 12 Octubre Avda. de Córdoba

    Madrid, 28041, Spain

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, 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

  • Start Madrid-FJD, Fundación Jimѐnez Díaz

    Madrid, 28040, Spain

  • Tennessee Oncology - Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Vanderbilt - Ingram Cancer Center

    Nashville, Tennessee, 37203, United States

  • Washington University - School of Medicine

    St Louis, Missouri, 63110, United States

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