Trial Search Results
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) .
Stanford is currently accepting patients for this trial.
- Genetic: afamitresgene autoleucel (previously ADP-A2M4)
Key Inclusion Criteria
- Age ≥16 (10 years at selected sites) and <=75 years
- 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:
Lansky Score ≥60%.
• Left ventricular ejection fraction (LVEF) ≥50%.
Note: other protocol defined Inclusion criteria may apply
Key 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
- 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
Note: other protocol defined Exclusion criteria may apply.
Ages Eligible for Study
10 Years - 75 Years
Genders Eligible for Study