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

August 30, 2021 updated by: MaxCyte, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Rockville, Maryland, United States, 20892
        • National Cancer Institute, National Institutes of Health
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University at St. Louis
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Drug: Cyclophosphamide
Intravenous administration for preconditioning
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)
Biological: MCY-M11
Intraperitoneal administration
Drug: Cyclophosphamide
Intravenous administration for preconditioning
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)
Biological: MCY-M11
Intraperitoneal administration
Drug: Cyclophosphamide
Intravenous administration for preconditioning
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)
Biological: MCY-M11
Intraperitoneal administration
Drug: Cyclophosphamide
Intravenous administration for preconditioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from first MCY-M11 dosing to first documented progression, assessed up to 24 months
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
from first MCY-M11 dosing to first documented progression, assessed up tp 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MaxCyte, Inc.

Collaborators

CTI Clinical Trial and Consulting Services

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2018

Primary Completion (Actual)

February 11, 2021

Study Completion (Actual)

August 24, 2021

Study Registration Dates

First Submitted

July 16, 2018

First Submitted That Met QC Criteria

July 24, 2018

First Posted (Actual)

August 1, 2018

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-M11-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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