Title
Intraperitoneal MCY-M11 (Mesothelin-targeting CAR) for Treatment of Advanced Ovarian Cancer and Peritoneal Mesothelioma
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
Phase
Phase 1Lead Sponsor
MaxCyte, Inc.Study Type
InterventionalStatus
TerminatedIntervention/Treatment
MCY-M11 ...Study Participants
14This 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.
Intraperitoneal administration
Intravenous administration for preconditioning
3-6 subjects will receive a starting dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks
3-6 subjects will receive a higher dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks (cohort 2); 3-6 subjects will receive MCY-M11 and cyclophosphamide preconditioning (cohort 2i)
3-6 subjects will receive a higher dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks (cohort 3); 3-6 subjects will receive MCY-M11 and cyclophosphamide preconditioning (cohort 3i)
3-6 subjects will receive a higher dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks (cohort 4); 3-6 subjects will receive MCY-M11 and cyclophosphamide preconditioning (cohort 4i)
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
