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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 of genetically engineered ADP-A2M4 in HLA-A*02 subjects with metastatic or inoperable (advanced) Synovial Sarcoma or MRCLS who have received prior chemotherapy and whose tumor expresses the MAGE-A4 tumor antigen.
Sarcoma
Phase II
Adults
Chemotherapy - cytotoxic, Gene Therapy
ADP-A2M4, Cyclophosphamide, Fludarabine (Fludara)
Keedy, Vicki
National
Vanderbilt University
12-02-2019
Treatment
VICCSAR1948
NCT04044768

Eligibility

16 Years
BOTH
NO
Inclusion Criteria:

Age ?16 and
Diagnosis of advanced synovial sarcoma or myxoid liposarcoma / myxoid round cell liposarcoma 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.

Left ventricular ejection fraction (LVEF) ?40%.



Exclusion Criteria:

HLA-A*02:05 in either allele; HLA-A*02:07 or any A*02 null allele as the sole HLA-A*02 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

Leptomeningeal disease, carcinomatous meningitis or symptomatic CNS metastases.

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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