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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03608618
Other study ID # CP-M11-101
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


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
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