Clinical Trial Begins for Innovative Immunotherapy Treatment for Peritoneal Mesothelioma
A clinical trial for the treatment of peritoneal mesothelioma and advanced ovarian cancer has begun at two locations in Maryland and Missouri. Sponsored by biotech company MaxCyte, Inc. and in collaboration with CTI Clinical Trial and Consulting Services, the clinical trial is designed to evaluate MaxCyte’s lead wholly-owned chimeric antigen receptor (CAR) therapeutic candidate, MCY-M11. This mesothelin targeting CAR will be studied in individuals with peritoneal mesothelioma with recurrence after chemotherapy and those with relapsed/refractory ovarian cancer.
The phase 1 dose escalation study will characterize the feasibility, safety and tolerability of MCY-M11 when administered as an intraperitoneal (IP) infusion for three weekly doses for subjects in both groups. MaxCyte anticipates 15 study participants enrolled across the two clinical sites—the National Cancer Institute at the National Institutes of Health (NIH) in Rockville, Maryland and Washington University at St. Louis in St. Louis, Missouri.
In a MaxCyte press release about the trial, company CEO Doug Doerfler said, “the initiation of patient dosing in our first clinical trial with our lead CAR therapeutic candidate is a significant milestone for MaxCyte, validating our streamlined manufacturing process for clinical use.”
“We are extremely pleased to have very experienced investigators at two leading clinical centers conducting this study in solid tumors. We believe this clinical trial will further demonstrate the potential of our proprietary CARMA (CAR therapeutic) autologous cell-therapy platform to develop meaningful, targeted cell-based immune therapies.”
Per the release, CARMA utilizes messenger RNA (mRNA) as the delivery vehicle for a CAR transfected into freshly isolated peripheral blood mononuclear cells, allowing for rapid manufacture and delivery back to the patient, without the need for a viral component or cell expansion. The CARMA platform provides a cell therapy with transient expression, enabling repeat dosing and with the potential to reduce the cost and minimize adverse side-effects seen in viral-based CAR therapies.
“In recent years,” explained MaxCyte Chief Medical Officer Claudio Dansky Ullmann, “we have seen tremendous progress in the treatment of some types of cancer, but there remains a significant need to explore novel treatments that may benefit patients.”
“Individuals with advanced and relapsed ovarian cancer or peritoneal mesothelioma have limited effective therapeutic options today,” he said. “MCY-M11 is an exciting new approach with the potential to improve outcomes for these patients. We look forward to the continued progress of this first clinical study.”
For additional details about this study, visit ClinicalTrails.gov.
If you have been diagnosed with peritoneal mesothelioma, you may be eligible to participate in a study that investigates new and innovative treatments for the disease. However, choosing to participate in a study is an important personal decision, so talk with your doctor and family members or friends about your decision to join a study.
“Intraperitoneal MCY-M11 (Mesothelin-targeting CAR) for Treatment of Advanced Ovarian Cancer and Peritoneal Mesothelioma.” National Institutes of Health (NIH). U.S. National Library of Medicine, 20 Sep. 2018. Web. 04 Mar. 2019.
“MaxCyte Commences Dosing in First Clinical Trial in Solid Tumors.” MaxCyte, Inc. MaxCyte, Inc., 10 Oct. 2018. Web. 04 Mar. 2019.