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Trial record 1 of 1 for:    MaxCyte
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Intraperitoneal MCY-M11 (Mesothelin-targeting CAR) for Treatment of Advanced Ovarian Cancer and Peritoneal Mesothelioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03608618
Recruitment Status : Terminated (Sponsor shift in focus)
First Posted : August 1, 2018
Last Update Posted : September 5, 2021
Sponsor:
Collaborator:
CTI Clinical Trial and Consulting Services
Information provided by (Responsible Party):
MaxCyte, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Peritoneal Mesothelioma Fallopian Tube Adenocarcinoma Adenocarcinoma of the Ovary Primary Peritoneal Carcinoma Biological: MCY-M11 Drug: Cyclophosphamide Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 27, 2018
Actual Primary Completion Date : February 11, 2021
Actual Study Completion Date : August 24, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1
3-6 subjects will receive a starting dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks
 Biological: MCY-M11
Intraperitoneal administration

Drug: Cyclophosphamide
Intravenous administration for preconditioning
Experimental: 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)
 Biological: MCY-M11
Intraperitoneal administration

Drug: Cyclophosphamide
Intravenous administration for preconditioning
Experimental: 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)
 Biological: MCY-M11
Intraperitoneal administration

Drug: Cyclophosphamide
Intravenous administration for preconditioning
Experimental: 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)
 Biological: MCY-M11
Intraperitoneal administration

Drug: Cyclophosphamide
Intravenous administration for preconditioning


Outcome Measures
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Primary Outcome Measures :
  1. Incidence and severity of adverse events as assessed by CTCAE v.5.0 [ Time Frame: 6 weeks ]
    number and severity of adverse events according to NCI CTCAE v.5.0


Secondary Outcome Measures :
  1. Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: from first MCY-M11 dosing to first documented progression, assessed up to 24 months ]
    tumor response scored by RECIST criteria

  2. Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) [ Time Frame: from first MCY-M11 dosing to first documented progression, assessed up tp 24 months ]
    tumor response scored by irRECIST criteria


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03608618


Locations
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United States, Maryland
National Cancer Institute, National Institutes of Health
Rockville, Maryland, United States, 20892
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Missouri
Washington University at St. Louis
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
MaxCyte, Inc.
CTI Clinical Trial and Consulting Services
Investigators
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Study Director: Claudio Dansky Ullmann, MD MaxCyte, Inc.
More Information
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Responsible Party: MaxCyte, Inc.
ClinicalTrials.gov Identifier: NCT03608618    
Other Study ID Numbers: CP-M11-101
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MaxCyte, Inc.:
platinum resistant
high grade serous adenocarcinoma
recurrence after chemotherapy
intraperitoneal
Additional relevant MeSH terms:
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Adenocarcinoma
Mesothelioma
Mesothelioma, Malignant
Carcinoma, Ovarian Epithelial
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenoma
Neoplasms, Mesothelial
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Pleural Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Ovarian Neoplasms
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders