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

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ClinicalTrials.gov Identifier: NCT03608618
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : September 20, 2018
Sponsor:
Collaborator:
CTI Clinical Trial and Consulting Services
Information provided by (Responsible Party):
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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 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
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


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

Experimental: Cohort 2
3-6 subjects will receive a higher dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks
Biological: MCY-M11
Intraperitoneal administration

Experimental: Cohort 3
3-6 subjects will receive a higher dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks
Biological: MCY-M11
Intraperitoneal administration

Experimental: Cohort 4
3-6 subjects will receive a higher dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks
Biological: MCY-M11
Intraperitoneal administration




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: 6 weeks ]
    tumor response scored by RECIST criteria

  2. Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) [ Time Frame: 6 weeks ]
    tumor response scored by irRECIST criteria



Information from the National Library of Medicine

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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

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


Contacts
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Contact: Claudio Dansky Ullmann, MD 617-806-6190 cdanskyullmann@maxcyte.com
Contact: David Weng, MD, PhD 877-597-8986 dweng@aahs.org

Locations
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United States, Maryland
National Cancer Institute, National Institutes of Health Recruiting
Rockville, Maryland, United States, 20892
Contact: Christina Annunziata, MD, PhD    888-624-1937    annunzic@mail.nih.gov   
Contact: Cynthia Boyle    240-760-6006      
United States, Missouri
Washington University at St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Premal Thaker, MD    800-856-7196      
Sponsors and Collaborators
MaxCyte, Inc.
CTI Clinical Trial and Consulting Services
Investigators
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Study Director: Claudio Dansky Ullmann, MD MaxCyte, Inc.

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Responsible Party: MaxCyte, Inc.
ClinicalTrials.gov Identifier: NCT03608618     History of Changes
Other Study ID Numbers: CP-M11-101
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
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
Carcinoma, Ovarian Epithelial
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenoma
Neoplasms, Mesothelial
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders