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

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.

Tracking Information
First Received DateJuly 16, 2018
Last Changed DateSeptember 19, 2018
Start DateAugust 27, 2018
Anticipated Primary Completion DateDecember 2020
Primary Outcome Measures

Incidence and severity of adverse events as assessed by CTCAE v.5.0 [Time Frame: 6 weeks]

Secondary Outcome Measures

Response Evaluation Criteria in Solid Tumors (RECIST) [Time Frame: 6 weeks]

Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) [Time Frame: 6 weeks]

Descriptive Information
PhasePhase 1
Study TypeInterventional
  • Peritoneal Mesothelioma
  • Fallopian Tube Adenocarcinoma
  • Adenocarcinoma of the Ovary
  • Primary Peritoneal Carcinoma
  • Biological: MCY-M11
Study Arms / Comparison Groups4 / 0
Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment15
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Contact Claudio Dansky Ullmann, MD
Phone: 617-806-6190
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

Administrative Information
Responsible PartySponsor
SponsorMaxCyte, Inc.
Verification DateSeptember 2018
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