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Trial record 1 of 1 for:    MCY-M11
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03608618
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : October 23, 2019
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 October 23, 2019
Actual Study Start Date  ICMJE August 27, 2018
Estimated Primary Completion Date December 2020   (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: 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
Original Secondary Outcome Measures  ICMJE Same as current
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.
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
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
    Intervention: Biological: MCY-M11
  • Experimental: Cohort 2
    3-6 subjects will receive a higher dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks
    Intervention: Biological: MCY-M11
  • Experimental: Cohort 3
    3-6 subjects will receive a higher dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks
    Intervention: Biological: MCY-M11
  • Experimental: Cohort 4
    3-6 subjects will receive a higher dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks
    Intervention: Biological: MCY-M11
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 24, 2018)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (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: Claudio Dansky Ullmann, MD 617-806-6190 cdanskyullmann@maxcyte.com
Contact: Eduardo Pennella, MD 301-798-6591 epennella@maxcyte.com
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 October 2019

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