Lead Sponsor

USWM CT, LLC

Age

2 - 21 years

Sex

ALL

Healthy Volunteers

No

•Subject has histologically confirmed diagnosis of any one of the following cancers: (A) Synovial Sarcoma (SS), (B) MPNST, (C) Neuroblastoma, or (D) Osteosarcoma (OS).
•Age:
•(A) Synovial Sarcoma: 2 to 17 years (B) MPNST, Neuroblastoma and Osteosarcoma: 2 to 21 years
•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).
•HLA-A\*02 positive
•Tumor shows MAGE-A4 expression confirmed by central laboratory.
•Performance Status:
•(A) Subjects ≥16: Eastern Cooperative Oncology Group (ECOG) 0 or 1 (B) Subjects 2 to 16: Lansky score ≥ 80
•Subject has anticipated life expectancy of greater than 3 months in the opinion of the investigator.

•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.
•Other prior malignancy that is not considered by the Investigator to be in complete remission
•Clinically significant cardiovascular disease
•Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus
•Pregnant or breastfeeding
•Experiencing ongoing rapid disease progression that in the opinion of the Investigator significantly increases the subjects risk associated with treatment.

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