T-Cell Infusion, Aldesleukin, and Utomilumab in Treating Patients With Recurrent Ovarian Cancer

Inclusion Criteria

• Histopathologic documentation (must be performed or reviewed at MD Anderson) of recurrent high grade epithelial ovarian cancer.
• At least one prior line of platinum-based chemotherapy (subjects are eligible for enrollment and leukapheresis while still platinum-sensitive, however, they must have developed platinum resistant disease for treatment (turnstile 2).
• Tumor expressing PRAME and/or COL6A3.
• Expression of HLA-A*0201.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Expected survival of greater than 16 weeks.
• Willing and able to give informed consent.
• Hemoglobin >= 9.0 g/dL.
• Absolute neutrophil count (ANC) >= 1.0 x 10^9/L (>=1000 per mm^3).
• Platelet count >= 75 x 10^9/L (>=100,000 per mm^3).
• Serum bilirubin = 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance.
• Subjects must either be of non-reproductive potential (i.e., post-menopausal by history: >= 50 years old and no menses for >=1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.
• Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. Suggested precautions should be used to minimize the risk or pregnancy for at least 1 month before start of therapy, and while women are on study for up to 3 months after T cell infusion, and at least 8 weeks after the study drug is stopped.
• {Turnstile 2} Subjects must have platinum resistant disease (progression on a platinum-containing regimen or recurrence within 180 days of last dose of platinum-containing chemotherapy). Subjects that are not platinum resistant but are deemed not to be candidates for platinum-based chemotherapy due to prior significant allergic reaction may participate with principal investigator (PI) approval.
• {Turnstile 2} Bi-dimensionally measurable disease by radiographic imaging (magnetic resonance imaging [MRI] or computed tomography [CT] scan).
• {Turnstile 2} At least 4 weeks must have elapsed since the last chemotherapy, immunotherapy, radiotherapy or major surgery. At least 6 weeks for bevacizumab.
• {Turnstile 2} Toxicity related to prior therapy must either have returned to = = 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE > grade 1.
• History of allogeneic organ transplant.
• Unresolved partial or complete small or large bowel obstruction.
• {Turnstile 2} Receipt of live attenuated vaccination within 30 days prior to enrollment or within 30 days of planned lymphodepletion.
• Any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events.
• Active viral hepatitis.
• Confirmed human immunodeficiency virus (HIV) infection.