Ovarian Cancer Clinical Trial
Intraperitoneal MCY-M11 (Mesothelin-targeting CAR) for Treatment of Advanced Ovarian Cancer and Peritoneal Mesothelioma
Summary
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. The study will also assess multiple cycles of treatment and adding preconditioning with cyclophosphamide.
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
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There are 4 Locations for this study
Rockville Maryland, 20892, United States
Boston Massachusetts, 02114, United States
Saint Louis Missouri, 63110, United States
Hackensack New Jersey, 07601, United States
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