Intraperitoneal MCY-M11 (Mesothelin-targeting CAR) for Treatment of Advanced Ovarian Cancer and Peritoneal Mesothelioma

August 10, 2018

Primary Outcome Measures

Incidence and severity of adverse events as assessed by CTCAE v.5.0 [ Time Frame: 6 weeks ]
number and severity of adverse events according to NCI CTCAE v.5.0

Secondary Outcome Measures

Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 6 weeks ]
tumor response scored by RECIST criteria
Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) [ Time Frame: 6 weeks ]
tumor response scored by irRECIST 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 CIncluSymptomatic or uncontrolled brain metastases requiring current treatment; Impaired cardiac function or clinically significant cardiac disease; Lack Concomitant chronic use of steroids or NSAIDsof 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 use of complementary or alternative medication or therapy; Autoimmune disease or inflammatory disease within previous 5 years

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