Intraperitoneal MCY-M11 (Mesothelin-targeting CAR) for Treatment of Advanced Ovarian Cancer and Peritoneal Mesothelioma
NCT ID: NCT03608618
Last Updated: 2021-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
14 participants
INTERVENTIONAL
2018-08-27
2021-08-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1
3-6 subjects will receive a starting dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks
MCY-M11
Intraperitoneal administration
Cyclophosphamide
Intravenous administration for preconditioning
Cohort 2 and 2i
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)
MCY-M11
Intraperitoneal administration
Cyclophosphamide
Intravenous administration for preconditioning
Cohort 3 and 3i
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)
MCY-M11
Intraperitoneal administration
Cyclophosphamide
Intravenous administration for preconditioning
Cohort 4 and 4i
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)
MCY-M11
Intraperitoneal administration
Cyclophosphamide
Intravenous administration for preconditioning
Interventions
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MCY-M11
Intraperitoneal administration
Cyclophosphamide
Intravenous administration for preconditioning
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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CTI Clinical Trial and Consulting Services
OTHER
MaxCyte, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Claudio Dansky Ullmann, MD
Role: STUDY_DIRECTOR
MaxCyte, Inc.
Locations
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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
Countries
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Other Identifiers
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CP-M11-101
Identifier Type: -
Identifier Source: org_study_id
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