Clinical Trials /

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

NCT03608618

Description:

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.

Related Conditions:
  • High Grade Fallopian Tube Serous Adenocarcinoma
  • High Grade Ovarian Serous Adenocarcinoma
  • Peritoneal Mesothelioma
  • Primary Peritoneal Serous Adenocarcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT03608618

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: CP-M11-101
  • NCT ID: NCT03608618

Conditions

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

Interventions

DrugSynonymsArms
MCY-M11Cohort 1
CyclophosphamideCohort 1

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Cohort 1Experimental3-6 subjects will receive a starting dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks
  • MCY-M11
  • Cyclophosphamide
Cohort 2 and 2iExperimental3-6 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)
  • MCY-M11
  • Cyclophosphamide
Cohort 3 and 3iExperimental3-6 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)
  • MCY-M11
  • Cyclophosphamide
Cohort 4 and 4iExperimental3-6 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)
  • MCY-M11
  • Cyclophosphamide

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
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence and severity of adverse events as assessed by CTCAE v.5.0
Time Frame:6 weeks
Safety Issue:
Description:number and severity of adverse events according to NCI CTCAE v.5.0

Secondary Outcome Measures

Measure:Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame:from first MCY-M11 dosing to first documented progression, assessed up to 24 months
Safety Issue:
Description:tumor response scored by RECIST criteria
Measure: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
Safety Issue:
Description:tumor response scored by irRECIST criteria

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:MaxCyte, Inc.

Trial Keywords

  • platinum resistant
  • high grade serous adenocarcinoma
  • recurrence after chemotherapy
  • intraperitoneal

Last Updated

January 25, 2021