NCT03132922

MAGE-A4ᶜ¹º³²T for Multi-Tumor

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Adaptimmune · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• 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

Interventions

Type	Name	Description
GENETIC	Autologous genetically modified MAGE-A4ᶜ¹º³²T cells	Infusion of autologous genetically modified MAGE-A4ᶜ¹º³²T on Day 1
RADIATION	Autologous 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

Timeline

• Start date: 2017-05-15
• Primary completion: 2022-12-27
• Completion: 2032-09-01
• First posted: 2017-04-28
• Last updated: 2024-01-22

Locations

11 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study