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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 : Active, not recruiting
First Posted : August 1, 2018
Last Update Posted : April 27, 2021
Sponsor:
Collaborator:
CTI Clinical Trial and Consulting Services
Information provided by (Responsible Party):
MaxCyte, Inc.

Tracking Information
First Submitted Date  ICMJE July 16, 2018
First Posted Date  ICMJE August 1, 2018
Last Update Posted Date April 27, 2021
Actual Study Start Date  ICMJE August 27, 2018
Actual Primary Completion Date February 11, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2020)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2018)
  • Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 6 weeks ]
    tumor response scored by RECIST criteria
  • Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) [ Time Frame: 6 weeks ]
    tumor response scored by irRECIST criteria
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intraperitoneal MCY-M11 (Mesothelin-targeting CAR) for Treatment of Advanced Ovarian Cancer and Peritoneal Mesothelioma
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Peritoneal Mesothelioma
  • Fallopian Tube Adenocarcinoma
  • Adenocarcinoma of the Ovary
  • Primary Peritoneal Carcinoma
Intervention  ICMJE
  • Biological: MCY-M11
    Intraperitoneal administration
  • Drug: Cyclophosphamide
    Intravenous administration for preconditioning
Study Arms  ICMJE
  • Experimental: Cohort 1
    3-6 subjects will receive a starting dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks
    Interventions:
    • Biological: MCY-M11
    • Drug: Cyclophosphamide
  • 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)
    Interventions:
    • Biological: MCY-M11
    • Drug: Cyclophosphamide
  • 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)
    Interventions:
    • Biological: MCY-M11
    • Drug: Cyclophosphamide
  • 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)
    Interventions:
    • Biological: MCY-M11
    • Drug: Cyclophosphamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 22, 2021)
14
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2018)
15
Estimated Study Completion Date  ICMJE May 2022
Actual Primary Completion Date February 11, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03608618
Other Study ID Numbers  ICMJE CP-M11-101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party MaxCyte, Inc.
Study Sponsor  ICMJE MaxCyte, Inc.
Collaborators  ICMJE CTI Clinical Trial and Consulting Services
Investigators  ICMJE
Study Director: Claudio Dansky Ullmann, MD MaxCyte, Inc.
PRS Account MaxCyte, Inc.
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP