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

Primary Purpose

Peritoneal Mesothelioma, Fallopian Tube Adenocarcinoma, Adenocarcinoma of the Ovary

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MCY-M11
Cyclophosphamide
Sponsored by
MaxCyte, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peritoneal Mesothelioma focused on measuring platinum resistant, high grade serous adenocarcinoma, recurrence after chemotherapy, intraperitoneal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cancer Institute, National Institutes of Health
  • Massachusetts General Hospital
  • Washington University at St. Louis
  • Hackensack University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2 and 2i

Cohort 3 and 3i

Cohort 4 and 4i

Arm Description

3-6 subjects will receive a starting dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks

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)

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)

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)

Outcomes

Primary Outcome Measures

Incidence and severity of adverse events as assessed by CTCAE v.5.0
number and severity of adverse events according to NCI CTCAE v.5.0

Secondary Outcome Measures

Response Evaluation Criteria in Solid Tumors (RECIST)
tumor response scored by RECIST criteria
Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
tumor response scored by irRECIST criteria

Full Information

First Posted
July 16, 2018
Last Updated
August 30, 2021
Sponsor
MaxCyte, Inc.
Collaborators
CTI Clinical Trial and Consulting Services
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1. Study Identification

Unique Protocol Identification Number
NCT03608618
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Sponsor shift in focus
Study Start Date
August 27, 2018 (Actual)
Primary Completion Date
February 11, 2021 (Actual)
Study Completion Date
August 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MaxCyte, Inc.
Collaborators
CTI Clinical Trial and Consulting Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Mesothelioma, Fallopian Tube Adenocarcinoma, Adenocarcinoma of the Ovary, Primary Peritoneal Carcinoma
Keywords
platinum resistant, high grade serous adenocarcinoma, recurrence after chemotherapy, intraperitoneal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
3-6 subjects will receive a starting dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks
Arm Title
Cohort 2 and 2i
Arm Type
Experimental
Arm Description
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)
Arm Title
Cohort 3 and 3i
Arm Type
Experimental
Arm Description
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)
Arm Title
Cohort 4 and 4i
Arm Type
Experimental
Arm Description
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)
Intervention Type
Biological
Intervention Name(s)
MCY-M11
Intervention Description
Intraperitoneal administration
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Intravenous administration for preconditioning
Primary Outcome Measure Information:
Title
Incidence and severity of adverse events as assessed by CTCAE v.5.0
Description
number and severity of adverse events according to NCI CTCAE v.5.0
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Response Evaluation Criteria in Solid Tumors (RECIST)
Description
tumor response scored by RECIST criteria
Time Frame
from first MCY-M11 dosing to first documented progression, assessed up to 24 months
Title
Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
Description
tumor response scored by irRECIST criteria
Time Frame
from first MCY-M11 dosing to first documented progression, assessed up tp 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio Dansky Ullmann, MD
Organizational Affiliation
MaxCyte, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
National Cancer Institute, National Institutes of Health
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Washington University at St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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