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

Primary Peritoneal Carcinoma Clinical Trial

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 Details — Status: Terminated

Administrative data

• NCT number: NCT03608618
• Other study ID #: CP-M11-101
• Status: Terminated
• Phase: Phase 1
• Start date: August 27, 2018
• Est. completion date: August 24, 2021

Study information

• Verified date: August 2021
• Source: MaxCyte, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: August 24, 2021
• Est. primary completion date: February 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Ovary
• Carcinoma, Ovarian Epithelial
• Fallopian Tube Adenocarcinoma
• Mesothelioma
• Peritoneal Mesothelioma
• Primary Peritoneal Carcinoma

Intervention

Biological:
• MCY-M11
Intraperitoneal administration

Drug:
• Cyclophosphamide
Intravenous administration for preconditioning

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	National Cancer Institute, National Institutes of Health	Rockville	Maryland
United States	Washington University at St. Louis	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
MaxCyte, Inc.	CTI Clinical Trial and Consulting Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Response Evaluation Criteria in Solid Tumors (RECIST)	tumor response scored by RECIST criteria	from first MCY-M11 dosing to first documented progression, assessed up to 24 months
Secondary	Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)	tumor response scored by irRECIST criteria	from first MCY-M11 dosing to first documented progression, assessed up tp 24 months