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Engineered T-Cells take aim at bladder, skin, and head and neck cancers
NCT ID NCT02989064
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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10 people
The number who actually took part.
- Started
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Oct 2016
- Finished
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Jun 2020
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
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Hospital Universitario 12 Octubre Avda. de Córdoba
Madrid, 28041, Spain
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
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Princess Margaret Cancer Centre
Toronto, Ontario, M5G1X6, Canada
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Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
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Start Madrid-FJD, Fundación Jimѐnez Díaz
Madrid, 28040, Spain
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Tennessee Oncology - Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
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Vanderbilt - Ingram Cancer Center
Nashville, Tennessee, 37203, United States
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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.
- Experimental pill HG146 put to the test against rare head and neck cancer
- Bladder-Sparing hope: cystoscopy tested to spot Cancer-Free bladders before surgery
- Can a dental assistant keep cancer Patients' mouths healthier during radiation?
- Can intensified chemotherapy before surgery clear bladder tumors?
- Why do Non-Smokers get head and neck cancer? scientists probe tumor DNA
- Re-irradiation plus cetuximab targets head and neck tumors that return