Summary
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.
Key Facts
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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 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. 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 disability * Clinically significant pericardial effusion * Pleural or peritoneal effusion that requires drainage for symptom management within 28 days of screening. * Active autoimmune disease requiring immunosuppressive therapy or uncontrolled with treatment. * Untreated brain metastasis. * Subjects unwilling to participate in an extended safety monitoring period.