This is a pediatric basket study to investigate the safety and efficacy of afamitresgene autoleucel in HLA-A\*02 eligible and MAGE-A4 positive subjects aged 2-17 years of age with advanced cancers.
Subject has histologically confirmed diagnosis of any one of the following cancers: (A) Synovial Sarcoma (SS), (B) MPNST, (C) Neuroblastoma, or (D) Osteosarcoma (OS).
Body weight ≥ 10 kg
Must have previously received a systemic chemotherapy
Measurable disease prior to lymphodepletion according to RECIST v1.1 (or INCR, 2017 Neuroblastoma only).
Positive for HLA-A*02:05 in either allele; or any A*02 having same protein sequence as HLA-A*02:05
History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide.
History of autoimmune or immune mediated disease
Known central nervous system (CNS) metastases.
USWM CT, LLC
Lead sponsor