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.
- Synovial Sarcoma
- Myxoid Liposarcoma
- Eligible Ages
- Between 16 Years and 75 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Age ≥16 and <=75 years
- 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%.
Note: other protocol defined Inclusion criteria may apply
- 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
Note: other protocol defined Exclusion criteria may apply.
- Phase 2
- Study Type
- Intervention Model
- Single Group Assignment
- Primary Purpose
- None (Open Label)
Autologous genetically modified ADP-A2M4
Study ContactAdaptimmune Patient Enquiries