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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

This is a study to investigate the efficacy and safety of ADP-A2M4 in HLA-A*02 eligible and
MAGE-A4 positive subjects with metastatic or inoperable (advanced) Synovial Sarcoma (Cohort 1
and Cohort 2) or MRCLS (Cohort 1) .
Phase II
Chemotherapy - cytotoxic, Gene Therapy
ADP-A2M4, Cyclophosphamide, Fludarabine (Fludara)
Keedy, Vicki
Vanderbilt University


10 Years
Inclusion Criteria:

Age 16 (10 years at selected sites) and
Diagnosis of advanced synovial sarcoma (Cohort 1 and Cohort 2) or myxoid liposarcoma / myxoid round cell liposarcoma (Cohort 1 only) confirmed by cytogenetics.

Previously received either an anthracycline or ifosfamide containing regimen.

Measurable disease according to RECIST v1.1.

HLA-A*02 positive

Tumor shows MAGE-A4 expression confirmed by central laboratory.

ECOG Performance Status of 0 or1. For subjects aged 10 to 16 years old:

Exclusion Criteria:

HLA-A*02:05 in either allele

History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study.

History of autoimmune or immune mediated disease

Symptomatic CNS metastases including leptomeningeal disease.

Other prior malignancy that is not considered by the Investigator to be in complete remission

Clinically significant cardiovascular disease

Uncontrolled intercurrent illness

Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus

Pregnant or breastfeeding

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