Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Key Inclusion Criteria:
- Age ≥16 (10 years at selected sites) and <= 75 years.
- Diagnosis of advanced synovial sarcoma (Cohort 1, Cohort 2 and Cohort 3) 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 prior to lymphodepletion.
- HLA-A*02:01, HLA-A*02:02, HLA-A*02:03 or HLA-A*02:06 positive.
- Tumor shows MAGE-A4 expression confirmed by central laboratory. North America Only (United States and Canada): Tumor (either an archival specimen or a fresh biopsy)
shows MAGE-A4 expression of ≥1+ staining in ≥10% of the cells by immunohistochemistry.
- ECOG Performance Status of 0 or1. For subjects aged ≥10 to ≥16 years old:
- Lansky Score ≥ 60%.
- Left ventricular ejection fraction (LVEF) ≥ 50%.
Key Exclusion Criteria:
- HLA-A*02:05 in either allele.
- Received or plans to receive the following therapy/treatment prior to leukapheresis or
lymphodepleting chemotherapy: Cytotoxic chemotherapy, Tyrosine kinase inhibitor (TKI) (e.g., pazopanib), Immune therapy (including monoclonal antibody therapy, checkpoint
inhibitors,), Anti-cancer Vaccine, Gene therapy using an integrating vector (subjects who have received a gene therapy using a lentiviral vector may be eligible for the
study), Corticosteroids or any other immunosuppressive therapy, Investigational treatment or interventional clinical trial, Allogeneic hematopoietic stem cell transplant, Radiotherapy to the target lesions, Major surgery.
- 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.
- Uncontrolled intercurrent illness including, but not limited to:
• Ongoing or active infection;
• Clinically significant cardiac disease defined by congestive heart failure New York Heart Association (NYHA) Class 3 or Class 4;
• Uncontrolled clinically significant arrhythmia;
• Acute Coronary Syndrome (ACS) (angina or MI) in last 6 months;
• Interstitial lung disease (subjects with existing pneumonitis as a result of radiation are not excluded);
• Subjects must not be oxygen dependent;
• Congenital or family history of long QT syndrome;
• Current uncontrolled hypertension despite optimal medical therapy;
• History of stroke or central nervous system bleeding; transient ischemic attack (TIA) or reversible ischemic neurologic deficit (RIND) in last 6 months;
• Incipient compression/occlusion of a vital structure (e.g., bronchus; superior vena cava; renal outflow tract) which cannot undergo prophylactic stenting;
• COVID-19 infection or a positive COVID-19 RT-PCR test within 28 days of leukapheresis or lymphodepleting chemotherapy. If a subject has a positive COVID-19 test, then 2 subsequent negative tests are required, taken at least 7 days apart.
- 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 Inclusion/Exclusion Criteria may apply.
Eligibility last updated 12/5/23. Questions regarding updates should be directed to the study team contact.