Latest T-Cell Study Opens for Mesothelioma Patients
May 16, 2019
Sarah Cannon Research Institute in Nashville, Tennessee, and MD Anderson Cancer Center in Houston have opened a much-anticipated clinical trial involving a novel T-cell therapy for patients with mesothelioma.
The two institutions are establishing dosage levels and measuring efficacy of TC-210, a type of immunotherapy that targets mesothelin, a cell surface protein highly expressed in several cancers.
The study also is open to patients with certain types of bile duct, ovarian and non-small cell lung cancer.
Participation is based upon individual levels of mesothelin expression.
Researchers at the two centers are hoping to enroll up to 90 participants combined for the study, which is expected to end in 2021.
The therapy TC-210 involves a genetic modification of a patient’s T cells, a type of white blood cell that is separated from the blood through a process known as leukapheresis.
Modification Based on Genetic Profile
The laboratory modification of the cells is based upon a patient’s genetic profile and the specific cancer. The process takes approximately four to five weeks to complete.
The modified T cells, unique to each patient, are then reintroduced with an ability to identify and potentially kill the tumor cells by targeting mesothelin.
Preclinical data, presented at the 2019 American Association for Cancer Research annual meeting in Atlanta, showed robust anti-tumor activity in laboratory mesothelioma cell samples and animal models.
Until recently, T-cell therapy had been effective only when treating blood cancers such as lymphoma and leukemia.
The U.S. Food and Drug Administration approved the first T-cell therapy for pediatric leukemia in 2017.
Solid tumors, in advanced stages, have been tougher to attack with this type of therapy.
Advances such as TC-210, though, are changing that perception. New technology has allowed TC-210 to exceed the laboratory performance of previous T-cell or CAR T-cell therapies that similarly targeted mesothelin.
TC-210 has produced fewer side effects and more sustainability in early testing.
Follow-Up Care Is Lengthy
Patients will be receiving the study drug as a one-time infusion and actively followed for three months.
There is the possibility of a second infusion if deemed necessary by the study physician.
One group of patients will receive only the study drug, while a larger group also will receive Keytruda (pembrolizumab), another immunotherapy drug that targets a different cell-surface protein.
Most of the patients also will receive cyclophosphamide — a preconditioning chemotherapy — for four consecutive days before receiving the TC-210 infusion.
Patients are required to return regularly to the clinic for two years, if applicable. A patient can be dropped earlier from the study if the disease worsens or serious side effects occur.
Blood samples are taken approximately 30 times throughout the clinical trial.
TC-210 is a product of TCR2 Therapeutics, a clinical-stage company based in Cambridge, Massachusetts. TCR2 Therapeutics is developing novel T-cell therapies for a wide range of hematologic cancers and solid tumors such as mesothelioma.
Many oncologists believe that some form of T-cell therapy will be the future of all cancer care.
T-Cell Therapy Research Is Booming
The National Cancer Institute recently awarded the Abramson Cancer Center a five-year, $10.7 million grant to help the development of T-cell therapy for mesothelioma and lung cancer.
Thoracic surgeon Dr. Prasad Adusumilli at Memorial Sloan Kettering Cancer Center has worked for more than a decade on developing this type of therapy for thoracic malignancies.
“I think this is going to chance the paradigm of treating mesothelioma,” he said in 2018.
In March 2019, Adusumilli presented a clinical evaluation that detailed a combination of genetically engineered T cells, Keytruda and cyclophosphamide that produced significant mesothelioma shrinkage in eight of his 11 patients.
Adusumilli, who is regarded as an international leader in the field, will unveil a follow-up study later in 2019.
“From what we’re seeing now, I’m optimistic,” he said. “We’re moving in the right direction.”