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

• ClinicalTrials.gov Identifier: NCT03608618
• Recruitment Status: Terminated
• First Posted: August 1, 2018
• Last Update Posted: September 5, 2021
• Sponsor: MaxCyte, Inc.
• Collaborator: CTI Clinical Trial and Consulting Services
• Information provided by (Responsible Party): MaxCyte, Inc.

Tracking Information

• First Submitted Date: July 16, 2018
• First Posted Date: August 1, 2018
• Last Update Posted Date: September 5, 2021
• Actual Study Start Date: August 27, 2018
• Actual Primary Completion Date: February 11, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: Intraperitoneal MCY-M11 (Mesothelin-targeting CAR) for Treatment of Advanced Ovarian Cancer and Peritoneal Mesothelioma
• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Peritoneal Mesothelioma
• Fallopian Tube Adenocarcinoma
• Adenocarcinoma of the Ovary
• Primary Peritoneal Carcinoma

Intervention

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

Study Arms

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: January 22, 2021): 14
• Original Estimated Enrollment (submitted: July 24, 2018): 15
• Actual Study Completion Date: August 24, 2021
• Actual Primary Completion Date: February 11, 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03608618
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Current Responsible Party: MaxCyte, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: MaxCyte, Inc.
• Original Study Sponsor: Same as current
• Collaborators: CTI Clinical Trial and Consulting Services

Investigators

• Study Director: Claudio Dansky Ullmann, MD; MaxCyte, Inc.

• PRS Account: MaxCyte, Inc.
• Verification Date: August 2021