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

Phase 1

Terminated

• Conditions: Peritoneal Mesothelioma; Adenocarcinoma of the Ovary; Primary Peritoneal Carcinoma; Fallopian Tube Adenocarcinoma
• Interventions: Biological: MCY-M11; Drug: Cyclophosphamide

• Registration Number: NCT03608618
• Lead Sponsor: MaxCyte, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-16
• Study First Submitted QC: 2018-07-24
• Study First Posted: 2018-08-01
• Study Start: 2018-08-27
• Primary Completion: 2021-02-11
• Status Verified: 2021-08
• Study Completion: 2021-08-24
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 3 and 3i	MCY-M11	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)
Cohort 4 and 4i	MCY-M11	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)
Cohort 1	MCY-M11	3-6 subjects will receive a starting dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks
Cohort 1	Cyclophosphamide	3-6 subjects will receive a starting dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks
Cohort 2 and 2i	MCY-M11	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)
Cohort 2 and 2i	Cyclophosphamide	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)
Cohort 3 and 3i	Cyclophosphamide	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)
Cohort 4 and 4i	Cyclophosphamide	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)

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events as assessed by CTCAE v.5.0	6 weeks	number and severity of adverse events according to NCI CTCAE v.5.0

Secondary Outcome Measures

Name	Time	Method
Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)	from first MCY-M11 dosing to first documented progression, assessed up tp 24 months	tumor response scored by irRECIST criteria
Response Evaluation Criteria in Solid Tumors (RECIST)	from first MCY-M11 dosing to first documented progression, assessed up to 24 months	tumor response scored by RECIST criteria

Trial Locations

Locations (4)

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

National Cancer Institute, National Institutes of Health; 🇺🇸 Rockville, Maryland, United States

Washington University at St. Louis; 🇺🇸 Saint Louis, Missouri, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States