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

This is a multi-center, open-label phase 1 dose escalation trial that uses a modified 3+3 design to identify a recommended phase 2 dose (RP2D) of AB-1015 cell product. Backfill cohorts will enroll additional subjects at doses deemed to be safe for a total enrollment of up to 12 subjects per each backfill cohort on the protocol.

Inclusion Criteria: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 progressionb) 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.Exclusion Criteria:Cytotoxic chemotherapy within 14 days of time of cell collection.Cytotoxic chemotherapy within 14 days of starting of conditioning chemotherapy.New York Heart Association functional class II-IV cardiovascular disabilityClinically significant pericardial effusionPleural or peritoneal effusion that cannot be treated with standard approaches.Active autoimmune disease requiring immunosuppressive therapy or uncontrolled with treatment.Untreated brain metastasis.Subjects unwilling to participate in an extended safety monitoring period.