Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
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) .
MAGE-A4 positive subjects with metastatic or inoperable (advanced) Synovial Sarcoma (Cohort 1
and Cohort 2) or MRCLS (Cohort 1) .
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
10 Years
BOTH
NO
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
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
