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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

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

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

NCT ID

NCT03608618

First Posted

July 16, 2018

Last Updated

August 30, 2021

Sponsor

MaxCyte, Inc.

Collaborators

CTI Clinical Trial and Consulting Services

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

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

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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