Intraperitoneal MCY-M11 (Mesothelin-targeting CAR) for Treatment of Advanced Ovarian Cancer and Peritoneal Mesothelioma
Peritoneal Mesothelioma, Fallopian Tube Adenocarcinoma, Adenocarcinoma of the Ovary
About this trial
This is an interventional treatment trial for Peritoneal Mesothelioma focused on measuring platinum resistant, high grade serous adenocarcinoma, recurrence after chemotherapy, intraperitoneal
Eligibility Criteria
Inclusion Criteria:
- Be able to undergo peripheral blood leukapheresis; have successful placement of an intraperitoneal catheter
- Be diagnosed with one of the following: metastatic or unresectable high grade serous adenocarcinoma involving the ovary, primary peritoneum, or fallopian tube with peritoneal involvement, not including mixed histologies, OR unresectable epithelioid or biphasic peritoneal mesothelioma
- Be at least 4 weeks from previous anti-cancer therapy
- Have a life expectancy of greater than 3 months.
Exclusion Criteria:
- Females who are pregnant, trying to become pregnant, or breastfeeding
- Diagnosis of HIV or chronic active Hepatitis B or C
- Symptomatic or uncontrolled brain metastases requiring current treatment
- Impaired cardiac function or clinically significant cardiac disease
- Lack of recovery of prior mild adverse events due to earlier therapies
- Active infection
- Another previous or current malignancy within the last 3 years, with exceptions
- Concomitant chronic use of steroids or NSAIDs
- Concomitant use of complementary or alternative medication or therapy
- Autoimmune disease or inflammatory disease within previous 5 years
Sites / Locations
- National Cancer Institute, National Institutes of Health
- Massachusetts General Hospital
- Washington University at St. Louis
- Hackensack University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Cohort 1
Cohort 2 and 2i
Cohort 3 and 3i
Cohort 4 and 4i
3-6 subjects will receive a starting dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks
3-6 subjects will receive a higher dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks (cohort 2); 3-6 subjects will receive MCY-M11 and cyclophosphamide preconditioning (cohort 2i)
3-6 subjects will receive a higher dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks (cohort 3); 3-6 subjects will receive MCY-M11 and cyclophosphamide preconditioning (cohort 3i)
3-6 subjects will receive a higher dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks (cohort 4); 3-6 subjects will receive MCY-M11 and cyclophosphamide preconditioning (cohort 4i)