AB-1015, an Integrated Circuit T (ICT) Cell Therapy in Patients With Platinum Resistant Epithelial Ovarian Cancer

Prior treatment

• Cytotoxic chemotherapy within 14 days of time of cell collection.
• Cytotoxic chemotherapy within 14 days of starting of conditioning chemotherapy.

Other illness

• New York Heart Association functional class II-IV cardiovascular disability
• Active autoimmune disease requiring immunosuppressive therapy or uncontrolled with treatment.

Other

• Clinically significant pericardial effusion
• Pleural or peritoneal effusion that requires drainage for symptom management within 28 days of screening.
• Untreated brain metastasis.
• Subjects unwilling to participate in an extended safety monitoring period.

• Recurrent, advanced, platinum resistant ovarian, fallopian tube, and primary peritoneal cancer and must have a histological diagnosis of a high-grade serous histology.
• a) Platinum resistant disease is defined as progression of disease within six months of platinum regimen.
• Doubling of cancer antigen 125 (CA-125) level on 2 successive measurements may be considered as meeting the definition of disease progression
• b) Have received at least 2 lines of prior therapy including a platinum-based regimen if eligible and a poly-ADP ribose polymerase (PARP) inhibitor if BRCA1/2 mutated. No more than 3 lines of prior therapy for the treatment of platinum resistant disease is permitted.
• Adequate organ function as per protocol definitions.
• Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1.
• Evaluable disease (dose escalation cohorts) or measurable disease (backfill cohorts) at time of enrollment as per protocol definitions.
• Negative pregnancy test for women of childbearing potential. Women of non-childbearing potential are those who have been surgically sterilized, have medically confirmed ovarian failure, or have not had menses within the past 12 months.