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Urinary Bladder CancerPhase 1NCT03132922

MAGE-A4ᶜ¹º³²T for Multi-Tumor

A Phase 1 study testing Autologous genetically modified MAGE-A4ᶜ¹º³²T cells and Autologous genetically modified MAGE-A4c1032T cells combined with low dose radiation in people with Urinary Bladder Cancer and Melanoma, run by USWM CT, LLC at 11 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study will investigate the safety and tolerability of MAGE-A4ᶜ¹º³²T cell therapy in subjects who have the appropriate HLA-A2 tissue marker and whose urinary bladder, melanoma, head and neck, ovarian, non-small cell lung, esophageal, gastric, synovial sarcoma, or myxoid/round call liposarcoma (MRCLS) tumor has the… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Autologous genetically modified MAGE-A4ᶜ¹º³²T cells and Autologous genetically modified MAGE-A4c1032T cells combined with low dose radiation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
11 sitesin 2 countries
Study dates
15 May 2017to Sep 2032
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 indicated tumor types
  • Subject is HLA-A*02 positive. (This determination will be made under screening protocol ADP-0000-001).
  • Subject's tumor shows expression of the MAGE-A4 RNA or protein. (This determination will be made under screening protocol ADP-0000-001).
  • Adequate organ function as indicated in the study protocol
  • Subject has measurable disease according to RECIST v1.1 criteria prior to lymphodepletion
  • Subject meets disease-specific requirements per protocol
  • 7. Subject has anticipated life expectancy > 6 months prior to leukapheresis and >3 months prior to lymphodepletion.

Who cannot join

  • Subject does not express appropriate HLA-A genotype
  • Subject is receiving excluded therapy/treatment per protocol
  • Subject has symptomatic CNS metastases.
  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

11 sites in 2 countries.

11 sites in 2 countries

United States10 sites

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • Duke University Medical Center, Duke Cancer Institute

    Durham, North Carolina, 27710

  • M.D. Anderson Cancer Center

    Houston, Texas, 77030

  • University of Miami

    Miami, Florida, 33136

  • Tennessee Oncology - Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Washington University

    St Louis, Missouri, 63112

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

Canada1 site

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G1X6

Other trials in Canada

About this study

Official title: Phase 1 Dose Escalation, Multi-tumor Study to Assess the Safety, Tolerability and Antitumor Activity of Genetically Engineered MAGE-A4ᶜ¹º³²T in HLA-A2+ Subjects With MAGE-A4 Positive Tumors

This study will investigate the safety and tolerability of MAGE-A4ᶜ¹º³²T cell therapy in subjects who have the appropriate HLA-A2 tissue marker and whose urinary bladder, melanoma, head and neck, ovarian, non-small cell lung, esophageal, gastric, synovial sarcoma, or myxoid/round call liposarcoma (MRCLS) tumor has the MAGE-A4 protein expressed. This study will take a subject's T cells and give them a T cell receptor protein that recognizes and attacks the tumors. This study has a substudy component that will investigate the safety and tolerability of MAGE-A4c1032T cell therapy in combination with low dose radiation in up to 10 subjects.

Being tested
Autologous genetically modified MAGE-A4ᶜ¹º³²T cells, Autologous genetically modified MAGE-A4c1032T cells combined with low dose radiation
Keywords
Cell Therapy, T Cell Therapy, SPEAR T Cell, MAGE-A4, Immuno-oncology, Metastatic, Urothelial Cancer, Previously Treated, T Cell Receptor, Squamous, adenosquamous, adenocarcinoma or large cell NSCLC, Squamous or adenocarcinoma esophageal cancer, Sarcoma, Melanoma, Bladder, Ovarian, Radiation therapy
Medical subject headings
Urinary Bladder Neoplasms, Melanoma, Head and Neck Neoplasms, Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung, Esophageal Neoplasms, Stomach Neoplasms, Sarcoma, Synovial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous genetically modified MAGE-A4ᶜ¹º³²T cellsGenetic

    Infusion of autologous genetically modified MAGE-A4ᶜ¹º³²T on Day 1

  • Autologous genetically modified MAGE-A4c1032T cells combined with low dose radiationRadiation

    Up to 10 subjects will be considered for Radiation sub-study. Radiation with an intensity of 1.4Gy for 5 days before infusion of MAGE-A4c1032T cells

Study groups in NCT03132922
Study groupRoleWhat they receive
Autologous genetically modified MAGE-A4ᶜ¹º³²T cellsExperimentalNot described
Receives: Genetic: Autologous genetically modified MAGE-A4ᶜ¹º³²T cells
Radiation Sub-Study: Autologous genetically modified MAGE-A4c1ExperimentalNot described
Receives: Radiation: Autologous genetically modified MAGE-A4c1032T cells combined with low dose radiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events (AE) Including Serious Adverse Events (SAE)

    An AE was defined as any untoward medical occurrence in a clinical study participant who received a pharmaceutical product, regardless of causality. An AE was , therefore, any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with AEs (including SAEs) are presented.

    Measured: From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years).

  2. Peak Persistence

    Peak persistence of afamitresgene autoleucel cells was reported as vector copy numbers per microgram of genomic DNA from peripheral blood mononuclear cell (PBMC).

    Measured: From afamitresgene autoleucel infusion up to 18 months post-infusion

  3. Replication Competent Lentivirus (RCL)

    The presence of RCL was assessed by quantitative polymerase chain reaction (qPCR) targeting a segment of the vesicular stomatitis virus glycoprotein (VSV-G) coding sequence.

    Measured: From afamitresgene autoleucel infusion to 3 months post-infusion

Secondary outcomes (7)

  1. Overall Response Rate (ORR)

    ORR, defined as the proportion of participants with Best Overall Response (BOR) of confirmed completed response (CR) or partial response (PR) among participants with measurable disease at Baseline. The ORR was based on the assessment of response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by local radiologist. Participants with unknown or missing response were treated as non-responders.

    Measured: From afamitresgene autoleucel infusion until disease progression/recurrence (up to 3.2 years)

  2. Best Overall Response (BOR)

    BOR was defined as the best response recorded from the date of T-cell infusion until disease progression. Response categories from best to worst were, confirmed CR, confirmed PR, stable disease (SD), progressive disease (PD), and not evaluable (NE) (per RECIST v1.1)

    Measured: From afamitresgene autoleucel infusion until disease progression/recurrence (up to 3.2 years)

  3. Time to Response (TTR)

    TTR was defined as the interval between the date of the first T-cell infusion and the earliest date of the first documented confirmed CR or confirmed PR.

    Measured: From afamitresgene autoleucel infusion until first documented confirmed CR or PR

  4. Duration of Response (DoR)

    DoR was measured from the first CR/PR (whichever was first recorded) until the first date of progressive disease.

    Measured: From initial confirmed response (DR or PR) until PD or censored date. is defined as all participants who had not experienced the event of interest (i.e. ongoing, event free) at the time of the data cut off (used for the analysis).

  5. Duration of Stable Disease (DoSD)

    DoSD was defined as the time from the date of T-cell infusion to the first date of the radiological PD. This analysis of DoSD only applied to participants with BOR as confirmed CR, confirmed PR, or confirmed SD.

    Measured: From date of afamitresgene autoleucel infusion to first date of radiological PD or censored date

  6. Progression Free Survival (PFS)

    PFS was defined as the time from the date of the first T-cell infusion to the first date of the radiological PD or death date (due to any reason), whichever event was earlier.

    Measured: From afamitresgene autoleucel infusion until first documented PD or death due to any cause, whichever comes first, or censored date.

  7. Overall Survival (OS)

    OS was defined as the time from the date of afamitresgene autoleucel infusion to the date of death (due to any reason).

    Measured: From afamitresgene autoleucel infusion until death due to any reason or censored date From afamitresgene autoleucel infusion until death due to any reason or censored date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2017
  2. Study start15 May 2017
  3. Primary completion27 Dec 2022
  4. Study completionSep 2032 (estimated)

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03132922
Sponsor's protocol ID
ADP-0044-001/RSS
Status last verified
May 2026
First submitted
25 Apr 2017
Last updated
4 Jun 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Hong DS, Van Tine BA, Biswas S, McAlpine C, Johnson ML, Olszanski AJ, Clarke JM, Araujo D, Blumenschein GR Jr, Kebriaei P, Lin Q, Tipping AJ, Sanderson JP, Wang R, Trivedi T, Annareddy T, Bai J, Rafail S, Sun A, Fernandes L, Navenot JM, Bushman FD, Everett JK, Karadeniz D, Broad R, Isabelle M, Naidoo R, Bath N, Betts G, Wolchinsky Z, Batrakou DG, Van Winkle E, Elefant E, Ghobadi A, Cashen A, Grand'Maison A, McCarthy P, Fracasso PM, Norry E, Williams D, Druta M, Liebner DA, Odunsi K, Butler MO. Autologous T cell therapy for MAGE-A4+ solid cancers in HLA-A*02+ patients: a phase 1 trial. Nat Med. 2023 Jan;29(1):104-114. doi: 10.1038/s41591-022-02128-z. Epub 2023 Jan 9.

    PubMed 36624315

  • Sanderson JP, Crowley DJ, Wiedermann GE, Quinn LL, Crossland KL, Tunbridge HM, Cornforth TV, Barnes CS, Ahmed T, Howe K, Saini M, Abbott RJ, Anderson VE, Tavano B, Maroto M, Gerry AB. Preclinical evaluation of an affinity-enhanced MAGE-A4-specific T-cell receptor for adoptive T-cell therapy. Oncoimmunology. 2019 Nov 24;9(1):1682381. doi: 10.1080/2162402X.2019.1682381. eCollection 2020.

    PubMed 32002290

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Autologous genetically modified MAGE-A4ᶜ¹º³²T cells and Autologous genetically modified MAGE-A4c1032T cells combined with low dose radiation in people with Urinary Bladder Cancer and Melanoma, run by USWM CT, LLC at 11 sites in 2 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 8 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 4 Jun 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, 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?

Yes. Results are posted in the registry (first posted 7 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Adverse Events (AE) Including Serious Adverse Events (SAE) (time frame: From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years).). The study lists 3 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 NCT03132922, which also lists 2 linked publications.

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 Jun 2026.

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MAGE-A4ᶜ¹º³²T for Multi-Tumor (NCT03132922) | AzTrials