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

Stopped early · Phase 1

Conditions studied: Peritoneal Mesothelioma, Fallopian Tube Adenocarcinoma, Adenocarcinoma of the Ovary, Primary Peritoneal Carcinoma

In brief

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.

Key facts

Study ID

NCT03608618

Run by

MaxCyte, Inc.

People needed

14

Starts

2018-08-27

Expected to finish

2021-08-24

Last updated by the study team

2021-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• National Cancer Institute, National Institutes of Health — Rockville, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Washington University at St. Louis — St Louis, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States

Full record on ClinicalTrials.gov

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