CI

At a glance

ClinicalIndex Comparison Record
Phase 1Active· 71 enrolled
Drug / intervention
Autologous genetically modified MAGE-A4ᶜ¹º³²T cells +1 moregenetic
Likely dose
Autologous MAGE-A4c1032T cells, infusion dose not specified; radiation substudy uses 1.4Gy x5 days pre-infusionAI-extracted
Key inclusion· 7
  • ✓Age 18-75 years at informed consent
  • ✓Histologically confirmed diagnosis of one of the indicated tumor types (bladder, melanoma, head/neck, ovarian, NSCLC, esophageal, gastric, synovial sarcoma)
  • ✓HLA-A*02 positive (determined by screening protocol ADP-0000-001)
  • ✓Tumor expresses MAGE-A4 RNA or protein (determined by screening protocol ADP-0000-001)
Key exclusion· 7
  • ✕Does not express HLA-A*02 genotype
  • ✕Symptomatic CNS metastases
  • ✕Active malignancy other than the tumor under study within 3 years prior to screening
  • ✕Uncontrolled intercurrent illness

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03132922
NCT03132922Phase 1Active
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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

USWM CT, LLC·interventional·Posted Apr 28, 2017·Updated Jun 4, 2026

In Brief

A Phase 1 clinical trial evaluating Autologous genetically modified MAGE-A4ᶜ¹º³²T cells and Autologous genetically modified MAGE-A4c1032T cells combined with low dose radiation for Urinary Bladder Cancer and 9 related conditions. Active but no longer recruiting, targeting 71 participants across 11 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary 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
CountriesCanada, United States
Collaborators--

Timeline

Phase 1Active
20172018201920202021202220232024202520262027202820292030203120322033
First PostedApr 28, 2017
Enrollment StartMay 15, 2017
Primary CompletionDec 27, 2022
Study CompletionSep 1, 2032
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 9.2 years ago

Interventions

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