ClinicalTrials.gg
Active, not recruitingNCT03132922Updated Jun 4, 2026Results posted

MAGE-A4ᶜ¹º³²T for Multi-Tumor

A Phase 1 interventional study of Autologous genetically modified MAGE-A4ᶜ¹º³²T cells and Autologous genetically modified MAGE-A4c1032T cells combined with low dose radiation in Urinary Bladder Cancer, Melanoma and Head and Neck Cancer, sponsored by USWM CT, LLC. Active, not recruiting at 11 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by USWM CT, LLC · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
71
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Urinary Bladder Cancer
  • Melanoma
  • Head and Neck Cancer
  • Ovarian Cancer
  • Non-Small Cell Lung Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Synovial Sarcoma
  • Myxoid Round Cell Liposarcoma
  • Gastroesophageal Junction

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
03

In context

Urinary Bladder Neoplasms

1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.

This study's enrollment of 71 is above the median of 60 across 1,296 interventional studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

USWM CT, LLC is the lead sponsor of 9 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subject is ≥18 to 75 years of age at the time of signing the study .
  2. Subject has 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 according to v1.1 criteria prior to lymphodepletion
  7. Subject meets disease-specific requirements per protocol

7. Subject has anticipated > 6 months prior to leukapheresis and >3 months prior to lymphodepletion.

Exclusion criteria

Exclusion Criteria:

  1. Subject does not express appropriate HLA-A genotype
  2. Subject is receiving excluded therapy/treatment per protocol
  3. Subject has symptomatic .
  4. Subject has any other active besides the tumor under study within 3 years prior to Screening. Subject has uncontrolled intercurrent illness.
  5. Subject has active infection with , , 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.
  • disease impinging on the spinal cord or threatening spinal cord compression.
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
71 participants (actual)

Study arms

  • Experimental
    Autologous genetically modified MAGE-A4ᶜ¹º³²T cells

    Genetic: Autologous genetically modified MAGE-A4ᶜ¹º³²T cells

  • Experimental
    Radiation Sub-Study: Autologous genetically modified MAGE-A4c1

    Radiation: Autologous genetically modified MAGE-A4c1032T cells combined with low dose radiation

Interventions

  • GeneticAutologous genetically modified MAGE-A4ᶜ¹º³²T cells

    Infusion of autologous genetically modified MAGE-A4ᶜ¹º³²T on Day 1

  • RadiationAutologous genetically modified MAGE-A4c1032T cells combined with low dose radiation

    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

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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).

    Time frame: 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.

    Time frame: From afamitresgene autoleucel infusion to 3 months post-infusion

Secondary outcomes

  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.

    Time frame: 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)

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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).

    Time frame: 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

07

Results

Posted May 7, 2026

Participant flow

This was an open-label Phase 1 dose escalation study of afamitresgene autoleucel in HLA-A\*02 positive participants with MAGE-A4 expressing unresectable locally advanced or metastatic cancer of the following types: urothelial, melanoma, head and neck, ovarian, NSCLC, esophageal (squamous and adenocarcinoma), gastric, synovial sarcoma, or MRCLS. This study had a substudy component that investigated the safety and tolerability of afamitresgene autoleucel in combination with low dose radiation.

Participant flow — Overall Study
MilestoneAfamitresgene Autoleucel, Group 1Afamitresgene Autoleucel, Group 2Afamitresgene Autoleucel, Group 3 + ExpansionSubstudy: Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
Started33324
Received afamitresgene autoleucel33324
Completed33294
Not completed0030
Withdrew: Ongoing in interventional phase at data cut-off (1sep2020)0030

Outcome measures

PrimaryAdverse 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.

Time frame:
From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years).
Reported as:
Count of participants · Participants
Adverse Events (AE) Including Serious Adverse Events (SAE)
ParticipantsAfamitresgene Autoleucel, Group 1Afamitresgene Autoleucel, Group 2Afamitresgene Autoleucel, Group 3 + ExpansionLow Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
Adverse Events (AE) Including Serious Adverse Events (SAE)33324
PrimaryPeak Persistence

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

Time frame:
From afamitresgene autoleucel infusion up to 18 months post-infusion
Reported as:
Mean · DNA copies/microgram
Peak Persistence
DNA copies/microgramAfamitresgene Autoleucel, Group 1Afamitresgene Autoleucel, Group 2Afamitresgene Autoleucel Group 3 + ExpansionSubstudy: Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
Peak Persistence10766.23 ± 12504.70588900.26 ± 53873.432165035.89 ± 99806.129185,532.5800 ± 116322.7494
PrimaryReplication 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.

Time frame:
From afamitresgene autoleucel infusion to 3 months post-infusion
Reported as:
Count of participants · Participants
Replication Competent Lentivirus (RCL)
ParticipantsAfamitresgene Autoleucel, Group 1Afamitresgene Autoleucel, Group 2Afamitresgene Autoleucel, Group 3 + ExpansionLow Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
Replication Competent Lentivirus (RCL)0000
SecondaryOverall 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.

Time frame:
From afamitresgene autoleucel infusion until disease progression/recurrence (up to 3.2 years)
Reported as:
Count of participants · Participants
Overall Response Rate (ORR)
ParticipantsAfamitresgene Autoleucel, Group 1Afamitresgene Autoleucel, Group 2Afamitresgene Autoleucel, Group 3 + ExpansionLow Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
Overall Response Rate (ORR)0090
SecondaryBest 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)

Time frame:
From afamitresgene autoleucel infusion until disease progression/recurrence (up to 3.2 years)
Reported as:
Count of participants · Participants
Best Overall Response (BOR)
ParticipantsAfamitresgene Autoleucel, Group 1Afamitresgene Autoleucel, Group 2Afamitresgene Autoleucel, Group 3 + ExpansionLow Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
Complete response0000
Partial response0091
Stable disease23143
Progressive disease (PD)1060
Not evaluable0030
SecondaryTime 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.

Time frame:
From afamitresgene autoleucel infusion until first documented confirmed CR or PR
Reported as:
Median · Weeks
Time to Response (TTR)
WeeksAfamitresgene Autoleucel, Group 1Afamitresgene Autoleucel, Group 2Afamitresgene Autoleucel, Group 3 + ExpansionLow Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
Time to Response (TTR)——6.4 (6.143 to 24.143)NA (NA to NA)
SecondaryDuration of Response (DoR)

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

Time frame:
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).
Reported as:
Mean · Weeks
Duration of Response (DoR)
WeeksAfamitresgene Autoleucel, Group 1Afamitresgene Autoleucel, Group 2Afamitresgene Autoleucel Group 3 + ExpansionSubstudy: Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
Duration of Response (DoR)——25.6 (12.286 to NA)NA (NA to NA)
SecondaryDuration 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.

Time frame:
From date of afamitresgene autoleucel infusion to first date of radiological PD or censored date
Reported as:
Median · Weeks
Duration of Stable Disease (DoSD)
WeeksAfamitresgene Autoleucel, Group 1Afamitresgene Autoleucel, Group 2Afamitresgene Autoleucel, Group 3 + ExpansionLow Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
Duration of Stable Disease (DoSD)12.3 (NA to NA)12.1 (NA to NA)20.4 (12.286 to 37.857)25.143 (13.143 to NA)
SecondaryProgression 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.

Time frame:
From afamitresgene autoleucel infusion until first documented PD or death due to any cause, whichever comes first, or censored date.
Reported as:
Median · Weeks
Progression Free Survival (PFS)
WeeksAfamitresgene Autoleucel, Group 1Afamitresgene Autoleucel, Group 2Afamitresgene Autoleucel, Group 3 + ExpansionLow Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
Progression Free Survival (PFS)8.9 (5.571 to 12.286)12.1 (10.857 to 12.143)12.4 (10.000 to 20.429)19.143 (11.571 to NA)
SecondaryOverall Survival (OS)

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

Time frame:
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
Reported as:
Median · Weeks
Overall Survival (OS)
WeeksAfamitresgene Autoleucel, Group 1Afamitresgene Autoleucel, Group 2Afamitresgene Autoleucel Group 3 + ExpansionSubstudy: Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
Overall Survival (OS)19.8 (18.857 to 20.714)NA (NA to NA)42.9 (25.429 to NA)NA (11.571 to NA)

Adverse events

Collected over From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Afamitresgene Autoleucel, Group 12/3 (66.7%)2/3 (66.7%)3/3 (100%)
Afamitresgene Autoleucel, Group 21/3 (33.3%)2/3 (66.7%)3/3 (100%)
Afamitresgene Autoleucel, Group 3 + Expansion15/32 (46.9%)23/32 (71.9%)32/32 (100%)
Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel2/4 (50%)3/4 (75%)4/4 (100%)
Most frequent serious events
Showing 10 of 44
Most frequent serious events
EventAfamitresgene Autoleucel, Group 1Afamitresgene Autoleucel, Group 2Afamitresgene Autoleucel, Group 3 + ExpansionLow Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
Cytokine release syndromeImmune system disorders1/30/38/320/4
SepsisInfections and infestations0/31/31/320/4
PancytopeniaBlood and lymphatic system disorders0/31/33/320/4
Atrial fibrillationCardiac disorders1/30/31/320/4
EncephalopathyNervous system disorders1/30/30/320/4
SyncopeNervous system disorders1/30/30/320/4
Pleural effusionRespiratory, thoracic and mediastinal disorders0/31/31/320/4
Small intestinal obstructionGastrointestinal disorders0/31/30/320/4
Muscular weaknessMusculoskeletal and connective tissue disorders1/30/30/320/4
HyponatraemiaMetabolism and nutrition disorders1/30/30/320/4
Most frequent other events
Showing 10 of 124
Most frequent other events
EventAfamitresgene Autoleucel, Group 1Afamitresgene Autoleucel, Group 2Afamitresgene Autoleucel, Group 3 + ExpansionLow Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
Lymphocyte count decreasedInvestigations3/33/331/324/4
White blood cell count decreasedInvestigations3/33/328/324/4
Neutrophil count decreasedInvestigations3/33/327/324/4
NauseaGastrointestinal disorders3/32/319/322/4
FatigueGeneral disorders3/32/319/322/4
PyrexiaGeneral disorders1/33/318/323/4
Decreased appetiteMetabolism and nutrition disorders3/32/311/321/4
HeadacheNervous system disorders0/33/37/322/4
AnaemiaBlood and lymphatic system disorders2/32/323/323/4
DyspnoeaRespiratory, thoracic and mediastinal disorders2/32/312/323/4

Baseline characteristics

Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel

Age, Categorical
Age, Categorical(Participants)Afamitresgene Autoleucel, Group 1Afamitresgene Autoleucel, Group 2Afamitresgene Autoleucel, Group 3 + ExpansionSubstudy: Low Dose Radiation (LDR) in Combination With Afamitresgene AutoleucelTotal
<=18 years00000
Between 18 and 65 years1324331
>=65 years208111
Sex: Female, Male
Sex: Female, Male(Participants)Afamitresgene Autoleucel, Group 1Afamitresgene Autoleucel, Group 2Afamitresgene Autoleucel, Group 3 + ExpansionSubstudy: Low Dose Radiation (LDR) in Combination With Afamitresgene AutoleucelTotal
Female3310319
Male0022123
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Afamitresgene Autoleucel, Group 1Afamitresgene Autoleucel, Group 2Afamitresgene Autoleucel, Group 3 + ExpansionSubstudy: Low Dose Radiation (LDR) in Combination With Afamitresgene AutoleucelTotal
Hispanic or Latino01102
Not Hispanic or Latino3231440
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Afamitresgene Autoleucel, Group 1Afamitresgene Autoleucel, Group 2Afamitresgene Autoleucel, Group 3 + ExpansionSubstudy: Low Dose Radiation (LDR) in Combination With Afamitresgene AutoleucelTotal
American Indian or Alaska Native00000
Asian00303
Native Hawaiian or Other Pacific Islander00000
Black or African American00011
White3329338
More than one race00000
Unknown or Not Reported00000
08

Study locations

11 sites
09

References and documents

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 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2017 to primary completion in Dec 2022, 67 months.

Results were first posted in May 2026, 3 years 4 months after primary completion.

Of 80 industry-sponsored phase 1 interventional studies under Urinary Bladder Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 66. This study's 67 months is above that.

Counting every sponsor, half of 145 studies reached it within 43 months; a quarter within 29 and three quarters within 66.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 25, 2017
First posted
Apr 28, 2017
StartActual
May 15, 2017
Primary completionActual
Dec 27, 2022
CompletionEst.
Sep 2032
Results first posted
May 7, 2026
Last update
Jun 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03132922
Lead sponsor
USWM CT, LLC
Responsible party
Sponsor
First posted
Apr 28, 2017
Start date
May 15, 2017
Primary completion
Dec 27, 2022
Completion
Sep 2032 (estimated)
Results posted
May 7, 2026
Last update
Jun 4, 2026

Study contacts

David Hong, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion