Clinical trial NCT03608618: Intraperitoneal MCY-M11 (Mesothelin-targeting CAR) for Treatment of Advanced Ovarian Cancer and Peritoneal Mesothelioma
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Peritoneal Mesothelioma
Fallopian Tube Adenocarcinoma
Adenocarcinoma of the Ovary
Primary Peritoneal Carcinoma
Keywords: platinum resistant
high grade serous adenocarcinoma
recurrence after chemotherapy
intraperitoneal
Lead sponsor: MaxCyte, Inc.
Sponsor class: INDUSTRY
Collaborators: name: CTI Clinical Trial and Consulting Services
First posted: 2018-08-01
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence and severity of adverse events as assessed by CTCAE v.5.0
timeFrame: 6 weeks
Secondary outcomes:
measure: Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: from first MCY-M11 dosing to first documented progression, assessed up to 24 months
measure: Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
timeFrame: from first MCY-M11 dosing to first documented progression, assessed up tp 24 months
Other outcomes:
Locations:
city: Rockville
country: United States
facility: National Cancer Institute, National Institutes of Health
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University at St. Louis
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
Study officials:
affiliation: MaxCyte, Inc.
name: Claudio Dansky Ullmann, MD
role: STUDY_DIRECTOR
References: