Urothelial CarcinomaPhase 1NCT02989064
MAGE-A10ᶜ⁷⁹⁶T for Urothelial Cancer, Melanoma or Head and Neck Cancers
A Phase 1 study testing Autologous genetically modified MAGE A10ᶜ⁷⁹⁶T cells in people with Urothelial Carcinoma and Head and Neck Cancer, run by Adaptimmune at 11 sites in 3 countries.
Trial summary
This Phase 1 study is designed as a cell dose escalation trial in HLA-A*02:01 and HLA-A*02:06 subjects with MAGE-A10 positive urothelial, melanoma or head and neck tumors. The study will enroll subjects between the ages of 18 and 75 using a modified 3+3 cell dose escalation design, to evaluate dose limiting toxicities… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Urothelial Carcinoma, Head and Neck Cancer, Melanoma
- What is being tested?
- Autologous genetically modified MAGE A10ᶜ⁷⁹⁶T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 11 sitesin 3 countries
- Study dates
- Oct 2016to 4 Jun 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥18 to ≤75 years of age at the time of signing the study informed consent.
- 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.
- Subject is HLA-A*02:01 and/or HLA-A*02:06 positive.
- Subject has measurable disease according to RECIST v1.1 criteria prior to lymphodepletion
- Subject meets disease-specific requirements per protocol
- Subject has anticipated life expectancy > 6 months prior to leukapheresis and >3 months prior to lymphodepletion.
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- Subject's tumor shows positive MAGE-A10 expression
- Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- Subject has a left ventricular ejection fraction ≥50%.
- Subject is fit for leukapheresis and has adequate venous access for the cell collection.
- 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.
- Subject must have adequate organ function per protocol
Who cannot join
- 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.
- Subject has received or plans to receive excluded therapy/treatment prior to leukapheresis or lymphodepleting chemotherapy per protocol
- Subject that has toxicity from previous anti-cancer therapy must have recovered to ≤ Grade 1 prior to enrollment
- 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.
- Subject had major surgery within 4 weeks prior to lymphodepletion; subjects should have been fully recovered from any surgical related toxicities.
- 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.
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- Subject has symptomatic CNS metastases.
- Subject has a history of chronic or recurrent severe autoimmune or immune mediated disease
- Subject has any other active malignancy besides the tumor under study within 3 years prior to Screening.
- Subject has uncontrolled intercurrent illness
- Subject has active infection with HIV, HBV, HCV or HTLV
- Subject is pregnant or breastfeeding.
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
United States8 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Roswell Park Cancer Institute
Buffalo, New York, 14263
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
MD Anderson Cancer Center
Houston, Texas, 77030
Tennessee Oncology - Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Vanderbilt - Ingram Cancer Center
Nashville, Tennessee, 37203
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Washington University - School of Medicine
St Louis, Missouri, 63110
Spain2 sites
Start Madrid-FJD, Fundación Jimѐnez Díaz
Madrid, 28040
Hospital Universitario 12 Octubre Avda. de Córdoba
Madrid, 28041
About this study
Official title: Phase 1 Cell Dose Escalation Study to Assess the Safety and Tolerability of Genetically Engineered MAGE-A10ᶜ⁷⁹⁶T in HLA-A2+ Subjects With MAGE-A10 Positive Urothelial, Melanoma or Head and Neck Tumors
This Phase 1 study is designed as a cell dose escalation trial in HLA-A*02:01 and HLA-A*02:06 subjects with MAGE-A10 positive urothelial, melanoma or head and neck tumors. The study will enroll subjects between the ages of 18 and 75 using a modified 3+3 cell dose escalation design, to evaluate dose limiting toxicities and determine the target cell dose range. Following the dose escalation phase, additional subjects will be enrolled at the target cell dose range to further characterize safety and the effects at this cell dose.
The study will take the subject's T cells, which are a natural type of immune cell in the blood, and send them to a laboratory to be modified. The changed T cells used in this study will be the subject's own T cells that have been genetically changed with the aim of attacking and destroying cancer cells. When the MAGE-A10ᶜ⁷⁹⁶T cells are available, subjects will undergo lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by T cell infusion. The purpose of this study is to test the safety of genetically changed T cells and find out what effects, if any, they have in subjects with urothelial, melanoma or head and neck cancer.
Subjects will be seen frequently by the Study Physician after receiving their T cells for the next 6 months. After that, subjects will be seen every 3, 6, or 12 months according to the Schedule of Procedures. All subjects completing or withdrawing from the interventional portion of the study will enter a long term follow-up phase for observation of delayed adverse events and overall survival for 15 years post-infusion.
- Being tested
- Autologous genetically modified MAGE A10ᶜ⁷⁹⁶T cells
- Keywords
- Cell Therapy, T Cell Therapy, SPEAR T Cell, MAGE-A10, Immuno-oncology, Metastatic, Urothelial Cancer, Previously Treated, T Cell Receptor, Inoperable, Advanced, Cancer, Bladder, Head and neck, Melanoma
- Medical subject headings
- Carcinoma, Transitional Cell, Head and Neck Neoplasms, Melanoma, Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous genetically modified MAGE A10ᶜ⁷⁹⁶T cellsGenetic
Infusion of autologous genetically modified MAGE A10ᶜ⁷⁹⁶T on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Autologous genetically modified MAGE A10ᶜ⁷⁹⁶T cells | Experimental | Not described Receives: Genetic: Autologous genetically modified MAGE A10ᶜ⁷⁹⁶T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events (AE), including serious adverse events (SAE).
Determine if treatment with autologous genetically modified T cells, (MAGE A10ᶜ⁷⁹⁶T ) is safe and tolerable through laboratory assessments including chemistry, hematology and coagulation; and cardiac assessments, including ECG/troponin.
Measured: 3 years
Evaluation of the persistence of genetically modified T cells
Evaluation of the persistence of the infused T cells in the periphery.
Measured: 3 years
Measurement of RCL in genetically modified T cells.
Evaluation of RCL in Subject PBMCs using PCR-based assay.
Measured: 3 years
Assessment of dose limiting toxicities to determine optimally tolerated dose range
Evaluation of dose limiting toxicities will be performed using the CTCAE Version 4.0
Measured: 3 years
Proportion of subjects with a confirmed Complete Response (CR) and/or Partial Response (PR).
Evaluation of the efficacy of the treatment by assessment of the Overall Response Rate according to RECIST v1.1
Measured: 3 years
Interval between the date of first T cell infusion dose and first documented evidence of CR or PR.
Evaluation of the efficacy of the treatment by assessment of time to first response.
Measured: 3 years
Interval between the date of first documented evidence of CR or PR until first documented disease progression or death due to any cause.
Evaluation of the efficacy of the treatment by assessment of duration of response.
Measured: 3 years
Interval between the date of first documented evidence of SD until first documented disease progression or death due to any cause.
Evaluation of the efficacy of the treatment by assessment of duration of stable disease.
Measured: 3 years
Interval between the date of first T cell infusion and the earliest date of disease progression or death due to any cause
Evaluation of the efficacy of the treatment by assessment of progression-free survival.
Measured: 3 years
Interval between the date of first T cell infusion and date of death due to any cause.
Evaluation of the efficacy of the treatment by assessment of overall survival.
Measured: 3 years
Number and % of subjects having any Long Term Follow Up Adverse Events (AEs)
- New occurrence of any malignancy
- New occurrence or exacerbation of a pre-existing neurologic disorder
- New occurrence or exacerbation of a prior rheumatologic or other autoimmune disorder
- New occurrence of a hematologic disorder
- New occurrence of any opportunistic and/or serious infections
- New occurrence of any unanticipated illness and/or hospitalization deemed related to gene modified cell therapy
Measured: 15 years post last treatment (infusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startOct 2016
- Primary completion18 Dec 2019
- Study completion4 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adaptimmune
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Hong, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989064
- Sponsor's protocol ID
- ADP-0022-004
- Status last verified
- Feb 2026
- First submitted
- 7 Nov 2016
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hong DS, Butler MO, Pachynski RK, Sullivan R, Kebriaei P, Boross-Harmer S, Ghobadi A, Frigault MJ, Dumbrava EE, Sauer A, Brophy F, Navenot JM, Fayngerts S, Wolchinsky Z, Broad R, Batrakou DG, Wang R, Solis LM, Duose DY, Sanderson JP, Gerry AB, Marks D, Bai J, Norry E, Fracasso PM. Phase 1 Clinical Trial Evaluating the Safety and Anti-Tumor Activity of ADP-A2M10 SPEAR T-Cells in Patients With MAGE-A10+ Head and Neck, Melanoma, or Urothelial Tumors. Front Oncol. 2022 Mar 18;12:818679. doi: 10.3389/fonc.2022.818679. eCollection 2022.
PubMed 35372008
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Cell Dose Escalation Study to Assess the Safety and Tolerability of Genetically Engineered MAGE-A10ᶜ⁷⁹⁶T in HLA-A2+ Subjects With MAGE-A10 Positive Urothelial, Melanoma or Head and Neck Tumors
- ClinicalTrials.gov ID
- NCT02989064
- Acronym / sponsor ID
- ADP-0022-004
- Keywords
- Cell Therapy, T Cell Therapy, SPEAR T Cell, MAGE-A10, Immuno-oncology, Metastatic, Urothelial Cancer, Previously Treated
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- AdaptimmuneIndustry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- 18 Dec 2019 (actual)
- Study completion
- 4 Jun 2020 (actual)
- First posted
- 12 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 1 study is designed as a cell dose escalation trial in HLA-A*02:01 and HLA-A*02:06 subjects with MAGE-A10 positive urothelial, melanoma or head and neck tumors. The study will enroll subjects between the ages of 18 and 75 using a modified 3+3 cell dose escalation design, to evaluate dose limiting toxicities and determine the target cell dose range. Following the dose escalation phase, additional subjects will be enrolled at the target cell dose range to further characterize safety and the effects at this cell dose.
The study will take the subject's T cells, which are a natural type of immune cell in the blood, and send them to a laboratory to be modified. The changed T cells used in this study will be the subject's own T cells that have been genetically changed with the aim of attacking and destroying cancer cells. When the MAGE-A10ᶜ⁷⁹⁶T cells are available, subjects will undergo lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by T cell infusion. The purpose of this study is to test the safety of genetically changed T cells and find out what effects, if any, they have in subjects with urothelial, melanoma or head and neck cancer.
Subjects will be seen frequently by the Study Physician after receiving their T cells for the next 6 months. After that, subjects will be seen every 3, 6, or 12 months according to the Schedule of Procedures. All subjects completing or withdrawing from the interventional portion of the study will enter a long term follow-up phase for observation of delayed adverse events and overall survival for 15 years post-infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous genetically modified MAGE A10ᶜ⁷⁹⁶T cells | Experimental | Genetic: Autologous genetically modified MAGE A10ᶜ⁷⁹⁶T cells |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject is ≥18 to ≤75 years of age at the time of signing the study informed consent.
- 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.
- Subject is HLA-A*02:01 and/or HLA-A*02:06 positive.
- Subject has measurable disease according to RECIST v1.1 criteria prior to lymphodepletion
- Subject meets disease-specific requirements per protocol
Key exclusion criteria (12 listed)
- 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.
- Subject has received or plans to receive excluded therapy/treatment prior to leukapheresis or lymphodepleting chemotherapy per protocol
- Subject that has toxicity from previous anti-cancer therapy must have recovered to ≤ Grade 1 prior to enrollment
- 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.
- Subject had major surgery within 4 weeks prior to lymphodepletion; subjects should have been fully recovered from any surgical related toxicities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous genetically modified MAGE A10ᶜ⁷⁹⁶T cellsInfusion of autologous genetically modified MAGE A10ᶜ⁷⁹⁶T on Day 1 | Genetic | Autologous genetically modified MAGE A10ᶜ⁷⁹⁶T cells |
Primary outcome
Number of subjects with adverse events (AE), including serious adverse events (SAE).
Time frame: 3 years
Determine if treatment with autologous genetically modified T cells, (MAGE A10ᶜ⁷⁹⁶T ) is safe and tolerable through laboratory assessments including chemistry, hematology and coagulation; and cardiac assessments, including ECG/troponin.
Evaluation of the persistence of genetically modified T cells
Time frame: 3 years
Evaluation of the persistence of the infused T cells in the periphery.
Measurement of RCL in genetically modified T cells.
Time frame: 3 years
Evaluation of RCL in Subject PBMCs using PCR-based assay.
Assessment of dose limiting toxicities to determine optimally tolerated dose range
Time frame: 3 years
Evaluation of dose limiting toxicities will be performed using the CTCAE Version 4.0
Proportion of subjects with a confirmed Complete Response (CR) and/or Partial Response (PR).
Time frame: 3 years
Evaluation of the efficacy of the treatment by assessment of the Overall Response Rate according to RECIST v1.1
Interval between the date of first T cell infusion dose and first documented evidence of CR or PR.
Time frame: 3 years
Evaluation of the efficacy of the treatment by assessment of time to first response.
Interval between the date of first documented evidence of CR or PR until first documented disease progression or death due to any cause.
Time frame: 3 years
Evaluation of the efficacy of the treatment by assessment of duration of response.
Interval between the date of first documented evidence of SD until first documented disease progression or death due to any cause.
Time frame: 3 years
Evaluation of the efficacy of the treatment by assessment of duration of stable disease.
Interval between the date of first T cell infusion and the earliest date of disease progression or death due to any cause
Time frame: 3 years
Evaluation of the efficacy of the treatment by assessment of progression-free survival.
Interval between the date of first T cell infusion and date of death due to any cause.
Time frame: 3 years
Evaluation of the efficacy of the treatment by assessment of overall survival.
Number and % of subjects having any Long Term Follow Up Adverse Events (AEs)
Time frame: 15 years post last treatment (infusion)
* New occurrence of any malignancy * New occurrence or exacerbation of a pre-existing neurologic disorder * New occurrence or exacerbation of a prior rheumatologic or other autoimmune disorder * New occurrence of a hematologic disorder * New occurrence of any opportunistic and/or serious infections * New occurrence of any unanticipated illness and/or hospitalization deemed related to gene modified cell therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Derived from this study: PubMed 35372008Hong DS, Butler MO, Pachynski RK, Sullivan R, Kebriaei P, Boross-Harmer S, Ghobadi A, Frigault MJ, Dumbrava EE, Sauer A, Brophy F, Navenot JM, Fayngerts S, Wolchinsky Z, Broad R, Batrakou DG, Wang R, Solis LM, Duose DY, Sanderson JP, Gerry AB, Marks D, Bai J, Norry E, Fracasso PM. Phase 1 Clinical Trial Evaluating the Safety and Anti-Tumor Activity of ADP-A2M10 SPEAR T-Cells in Patients With MAGE-A10+ Head and Neck, Melanoma, or Urothelial Tumors. Front Oncol. 2022 Mar 18;12:818679. doi: 10.3389/fonc.2022.818679. eCollection 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Hong, MD principal investigator
M.D. Anderson Cancer Center
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous genetically modified MAGE A10ᶜ⁷⁹⁶T cells in people with Urothelial Carcinoma and Head and Neck Cancer, run by Adaptimmune at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Spain, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse events (AE), including serious adverse events (SAE). (time frame: 3 years). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02989064, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.