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

NCT03608618 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-09-05

No results posted yet for this study

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

Interventions

BIOLOGICAL

MCY-M11

Intraperitoneal administration

DRUG

Cyclophosphamide

Intravenous administration for preconditioning

Sponsors & Collaborators

  • CTI Clinical Trial and Consulting Services

    collaborator OTHER

  • MaxCyte, Inc.

    lead INDUSTRY

Principal Investigators

  • Claudio Dansky Ullmann, MD · MaxCyte, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-27
Primary Completion
2021-02-11
Completion
2021-08-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03608618 on ClinicalTrials.gov