Melanoma-associated antigen A4-specific T-cells

Unassigned

New Medicines

Advanced synovial sarcoma or myxoid/round cell liposarcoma

Information

Advanced therapy medicinal product (ATMP)
Adaptimmune
Adaptimmune

Development and Regulatory status

Phase II Clinical Trials
Phase II Clinical Trials
Phase II Clinical Trials
Yes
Dec 19 · US FDA grants Regenerative Medicine Advanced Therapy Designation (RMAT) [4].
Sep 19 · US FDA grants orphan drug status to melanoma-associated antigen 4 (MAGE-A4) specific T-cell therapy for treatment of patients with soft tissue sarcoma [4].

Category

A genetically modified autologous melanoma-associated antigen 4 (MAGE A4) specific T cell therapy. SPEAR® technology works by modifying the complementarity-determining regions (CDRs) of the patient T-cells in order to enhance affinity to the cancer cell.
Soft tissue sarcomas develop from soft tissue cells including smooth muscle cells (leiomyosarcomas), fat cells (liposarcomas), fibrous connective tissue (fibrosarcomas), skeletal muscles (rhabdomyosarcomas), synovium (synovial sarcomas), blood vessels (angiosarcomas), breast ducts (phyllodes tumours) and nerves (nerve sheath tumours) [1]. Around 3,300 people were diagnosed with soft tissue sarcoma in 2010 in the UK [2].
Advanced synovial sarcoma or myxoid/round cell liposarcoma
Intravenous infusion

Trial or other data

Feb 20 · PII SPEARHEAD-1 trial is recruiting [3].
Jul 19 · PII SPEARHEAD-1 trial to assess antitumor activity of melanoma-associated antigen 4 (MAGE-A4) specific T-cell therapy, in patients with synovial sarcoma and myxoid/round cell liposarcoma (MRCLS) starts (ADP0044-002; NCT04044768). The trial will enrol 60 patients aged 16 to 75 years with inoperable or metastatic synovial sarcoma or MRCLS who have received prior chemotherapy, in the US, Canada, France, Spain and UK (sites are UCLH and The Christie). The primary endpoint is overall response rate; collection of these data is due to complete Jan 22. Subsequently a radiation sub-study was initiated to assess the effect of low-dose radiation on increasing anti-tumour activity and will enrol approximately 10 participants [3,4].