MAGE-A4ᶜ¹º³²T for Multi-Tumour

Official Title

Phase 1 Dose Escalation, Multi-tumour Study to Assess the Safety, Tolerability and Antitumour Activity of Genetically Engineered MAGE-A4ᶜ¹º³²T in HLA-A2+ Subjects With MAGE-A4 Positive Tumours

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) tumour 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 tumours. 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.

Trial Description

Primary Outcome:

• Number of subjects with adverse events (AE), including serious adverse events (SAEs).
• Determining dose limiting toxicities (DLT) and optimally tolerated dose range
• Evaluation of persistence of genetically modified T cells.
• Measurement of RCL in genetically modified T cells.

• Proportion of subjects with a confirmed Complete Response (CR) and/or Partial Response (PR).
• Interval between the date of first T cell infusion dose and first documented evidence of CR or PR.
• Interval between the date of first documented evidence of CR or PR until first documented disease progression or death due to any cause.
• Interval between the date of first documented evidence of stable disease (SD) until first documented disease progression or death due to any cause.
• Interval between the date of first T cell infusion and the earliest date of disease, progression or death due to any cause
• Interval between the date of first T cell infusion and date of death due to any cause.
• Number and % of subjects having any Long Term Follow Up Adverse Events (AEs)

View this trial on ClinicalTrials.gov