Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-22 @ 3:33 AM
Study NCT ID:
NCT03608618
Status:
TERMINATED
Last Update Posted:
2021-09-05
First Post:
2018-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraperitoneal MCY-M11 (Mesothelin-targeting CAR) for Treatment of Advanced Ovarian Cancer and Peritoneal Mesothelioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'whyStopped': 'Sponsor shift in focus', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-30', 'studyFirstSubmitDate': '2018-07-16', 'studyFirstSubmitQcDate': '2018-07-24', 'lastUpdatePostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of adverse events as assessed by CTCAE v.5.0', 'timeFrame': '6 weeks', 'description': 'number and severity of adverse events according to NCI CTCAE v.5.0'}], 'secondaryOutcomes': [{'measure': 'Response Evaluation Criteria in Solid Tumors (RECIST)', 'timeFrame': 'from first MCY-M11 dosing to first documented progression, assessed up to 24 months', 'description': 'tumor response scored by RECIST criteria'}, {'measure': 'Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)', 'timeFrame': 'from first MCY-M11 dosing to first documented progression, assessed up tp 24 months', 'description': 'tumor response scored by irRECIST criteria'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['platinum resistant', 'high grade serous adenocarcinoma', 'recurrence after chemotherapy', 'intraperitoneal'], 'conditions': ['Peritoneal Mesothelioma', 'Fallopian Tube Adenocarcinoma', 'Adenocarcinoma of the Ovary', 'Primary Peritoneal Carcinoma']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be able to undergo peripheral blood leukapheresis; have successful placement of an intraperitoneal catheter\n* 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\n* Be at least 4 weeks from previous anti-cancer therapy\n* Have a life expectancy of greater than 3 months.\n\nExclusion Criteria:\n\n* Females who are pregnant, trying to become pregnant, or breastfeeding\n* Diagnosis of HIV or chronic active Hepatitis B or C\n* Symptomatic or uncontrolled brain metastases requiring current treatment\n* Impaired cardiac function or clinically significant cardiac disease\n* Lack of recovery of prior mild adverse events due to earlier therapies\n* Active infection\n* Another previous or current malignancy within the last 3 years, with exceptions\n* Concomitant chronic use of steroids or NSAIDs\n* Concomitant use of complementary or alternative medication or therapy\n* Autoimmune disease or inflammatory disease within previous 5 years'}, 'identificationModule': {'nctId': 'NCT03608618', 'briefTitle': 'Intraperitoneal MCY-M11 (Mesothelin-targeting CAR) for Treatment of Advanced Ovarian Cancer and Peritoneal Mesothelioma', 'organization': {'class': 'INDUSTRY', 'fullName': 'MaxCyte, Inc.'}, 'officialTitle': 'A Phase 1 Study of Intraperitoneal MCY-M11 Therapy for Women With Platinum Resistant High Grade Serous Adenocarcinoma of the Ovary, Primary Peritoneum, or Fallopian Tube, or Subjects With Peritoneal Mesothelioma With Recurrence After Prior Chemotherapy', 'orgStudyIdInfo': {'id': 'CP-M11-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': '3-6 subjects will receive a starting dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks', 'interventionNames': ['Biological: MCY-M11', 'Drug: Cyclophosphamide']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 and 2i', 'description': '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)', 'interventionNames': ['Biological: MCY-M11', 'Drug: Cyclophosphamide']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3 and 3i', 'description': '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)', 'interventionNames': ['Biological: MCY-M11', 'Drug: Cyclophosphamide']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4 and 4i', 'description': '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)', 'interventionNames': ['Biological: MCY-M11', 'Drug: Cyclophosphamide']}], 'interventions': [{'name': 'MCY-M11', 'type': 'BIOLOGICAL', 'description': 'Intraperitoneal administration', 'armGroupLabels': ['Cohort 1', 'Cohort 2 and 2i', 'Cohort 3 and 3i', 'Cohort 4 and 4i']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Intravenous administration for preconditioning', 'armGroupLabels': ['Cohort 1', 'Cohort 2 and 2i', 'Cohort 3 and 3i', 'Cohort 4 and 4i']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Cancer Institute, National Institutes of Health', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University at St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}], 'overallOfficials': [{'name': 'Claudio Dansky Ullmann, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MaxCyte, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MaxCyte, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'CTI Clinical Trial and Consulting Services', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}