Clinical Trial Tests CAR T-Cell Therapy on Peritoneal Mesothelioma
December 18, 2018
The National Cancer Institute in Rockville, Maryland, has opened an innovative clinical trial for patients with peritoneal mesothelioma that will explore the safety and effectiveness of a novel CAR T-cell therapy.
The phase I trial also is being conducted at Washington University in St. Louis. It is aimed at patients whose disease has relapsed after initial chemotherapy treatment.
It involves a laboratory modification of a patient’s T cells — a type of white blood cell — that can help the immune system kill the cancer.
CAR T-cell therapy is a form of gene therapy that has been highly successful with blood and bone marrow cancers.
The U.S. Food and Drug Administration first approved the therapy in 2017 for pediatric leukemia.
“If it works well here, it could change the way [peritoneal mesothelioma] is treated in a relapsed setting,” Dr. Christina Annunziata, clinical director and principal investigator at the National Cancer Institute, told The Mesothelioma Center at Asbestos.com. “I’m excited about this one.”
Laboratory Reprograming of T Cells
This is a dose-escalation study that uses MCY-M11 as part of the laboratory reprograming.
MCY-M11 is a novel drug developed by MaxCyte, a global life-sciences and pharmaceutical company based in Gaithersburg, Maryland.
This is the first time the formula has been used in patients with peritoneal mesothelioma, which begins in the lining around the abdomen.
Modified T cells will be returned directly to the abdomen and the tumor site, instead of systemically — the more common reintroduction of the blood cells.
The study also will be evaluating MaxCyte’s delivery platform.
Unlike most CAR T-cell therapies, the modification of the cells in the study is designed to be more transient, which enables a quicker return to the patient and repeat dosing.
It is expected to minimize side effects and reduce costs. Patients in the study will receive treatment once each week for three consecutive weeks.
Also Recruiting for Ovarian Cancer
The clinical trial also is recruiting patients with recurrent ovarian cancer. The trial is scheduled to complete in December 2020.
“Individuals with advanced and relapsed ovarian cancer or peritoneal mesothelioma have limited effective options today,” said Dr. Claudio Dansky Ullmann, chief medical officer of MaxCyte, in a press release announcing the trial. “MCY-M11 is an exciting new approach with the potential to improve outcomes for these patients.”
MaxCyte is anticipating at least 15 participants across the two trial sites.
A similar trial with pancreatic cancer has shown promising results.
To qualify for the trial, patients must have a life expectancy of at least three months and be at least four weeks from previous anti-cancer therapy.
“Theoretically, if this works really well, it could be used at time of initial diagnosis,” Annunziata said. “That would be ideal.”
CAR T-Cell Therapy for Pleural Mesothelioma
CAR T-cell therapy is also being developed for pleural mesothelioma.
The National Cancer Institute recently awarded a $10.7 million grant to the Abramson Cancer Center in Philadelphia to help develop the therapy for lung cancer and pleural mesothelioma, which starts on the protective lining around the lungs.
Part of the project will include a clinical trial designed to target the mesothelin, a protein found on almost 90 percent of the tumors. It is the same target being used for treatment in the peritoneal study.
Memorial Sloan Kettering Cancer Center, under the direction of Dr. Prasad Adusumilli, also is conducting extensive testing of CAR T-cell therapy for pleural mesothelioma.
Adusumilli believes strongly this type of customized gene therapy is the future of cancer treatment.
He has worked for more than a decade on tumor immunology for thoracic cancers.
“We are going in the right direction with this,” Adusumilli said earlier this year. “I think this is going to change the paradigm of treating mesothelioma.”