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

This is a phase 1 dose escalation study to characterize the feasibility, safety and tolerability of MCY-M11 when administered as an intraperitoneal (IP) infusion for 3 weekly doses for women with platinum resistant high grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube, and subjects with peritoneal mesothelioma with recurrence after prior chemotherapy.

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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Source: the U.S. National Institutes of Health via Last updated: August 10th, 2018.

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Last update: May 07, 2019. 08:38:48 pm.