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
Overview
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- MaxCyte, Inc.
- Enrollment
- 14
- Locations
- 4
- Primary Endpoint
- Incidence and severity of adverse events as assessed by CTCAE v.5.0
Overview
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. The study will also assess multiple cycles of treatment and adding preconditioning with cyclophosphamide.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Cohort 1
3-6 subjects will receive a starting dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks
Intervention: MCY-M11 (Biological)
Cohort 1
3-6 subjects will receive a starting dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks
Intervention: Cyclophosphamide (Drug)
Cohort 2 and 2i
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)
Intervention: MCY-M11 (Biological)
Cohort 2 and 2i
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)
Intervention: Cyclophosphamide (Drug)
Cohort 3 and 3i
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)
Intervention: MCY-M11 (Biological)
Cohort 3 and 3i
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)
Intervention: Cyclophosphamide (Drug)
Cohort 4 and 4i
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)
Intervention: MCY-M11 (Biological)
Cohort 4 and 4i
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)
Intervention: Cyclophosphamide (Drug)
Outcomes
Primary Outcomes
Incidence and severity of adverse events as assessed by CTCAE v.5.0
Time Frame: 6 weeks
number and severity of adverse events according to NCI CTCAE v.5.0
Secondary Outcomes
- Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)(from first MCY-M11 dosing to first documented progression, assessed up tp 24 months)
- Response Evaluation Criteria in Solid Tumors (RECIST)(from first MCY-M11 dosing to first documented progression, assessed up to 24 months)