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

NCT03608618 | Terminated Phase 1 FDA Drug

• 1 other identifier: CP-M11-101
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  6 weeks

Secondary Outcomes (2)

• Response Evaluation Criteria in Solid Tumors (RECIST)

  from first MCY-M11 dosing to first documented progression, assessed up to 24 months

• Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)

  from first MCY-M11 dosing to first documented progression, assessed up tp 24 months

Study Arms (4)

Cohort 1

EXPERIMENTAL

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

Biological: MCY-M11; Drug: Cyclophosphamide

Cohort 2 and 2i

EXPERIMENTAL

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; Drug: Cyclophosphamide

Cohort 3 and 3i

EXPERIMENTAL

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; Drug: Cyclophosphamide

Cohort 4 and 4i

EXPERIMENTAL

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; Drug: Cyclophosphamide

Interventions

MCY-M11 BIOLOGICAL

Intraperitoneal administration

Cohort 1; Cohort 2 and 2i; Cohort 3 and 3i; Cohort 4 and 4i

Cyclophosphamide DRUG

Intravenous administration for preconditioning

Cohort 1; Cohort 2 and 2i; Cohort 3 and 3i; Cohort 4 and 4i

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MaxCyte, Inc.: lead
• CTI Clinical Trial and Consulting Services: collaborator

Study Sites (4)

National Cancer Institute, National Institutes of Health

Rockville, Maryland, 20892, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Washington University at St. Louis

St Louis, Missouri, 63110, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Interventions

Cyclophosphamide

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Claudio Dansky Ullmann, MD

  MaxCyte, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: August 1, 2018
• Study Start: August 27, 2018
• Primary Completion: February 11, 2021
• Study Completion: August 24, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-08

Locations

US (4)