Intraperitoneal MCY-M11 (Mesothelin-targeting CAR) for Treatment of Advanced Ovarian Cancer and Peritoneal Mesothelioma
| Status: | Recruiting |
|---|---|
| Conditions: | Lung Cancer, Ovarian Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/22/2018 |
| Start Date: | August 27, 2018 |
| End Date: | December 2020 |
| Contact: | Claudio Dansky Ullmann, MD |
| Email: | cdanskyullmann@maxcyte.com |
| Phone: | 617-806-6190 |
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
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.
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.
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
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Rockville, Maryland 20892
Phone: 888-624-1937
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