On September 23, 2019 City of Hope reported that it has opened and is treating the first patients in its CAR T cell trial for prostate cancer that has spread to other parts of the body (Press release, City of Hope, SEP 23, 2019, View Source [SID1234539717]). The trial uses a CAR T cell – also developed at City of Hope – that targets the prostate stem cell antigen (PSCA) in prostate cancer.
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The trial, which can enroll up to 33 patients, aims to find the appropriate dose of PSCA CAR T cells that a patient should receive and any side effects that the treatment may cause. Researchers will also study the expansion and persistence of the CAR T cells, survival outcomes and other findings.
Patients with PSCA-positive castration-resistant prostate cancer that has metastasized to other areas in the body, and who meet other requirements, are eligible for the trial, which includes the National Cancer Institute as a collaborator.
According to the American Cancer Society (ACS), other than skin cancer, prostate cancer is the most common cancer in American men. The ACS estimates that about 174,650 men will be diagnosed with new cases of prostate cancer and about 31,620 deaths will occur due to prostate cancer.
"Patients with advanced prostate cancer are in urgent need of a therapy that could provide a more durable remission," said Tanya Dorff, M.D., City of Hope associate clinical professor in the Department of Medical Oncology & Therapeutics Research, head of the Genitourinary Cancers Program and the trial’s principal investigator. "CAR T cell therapy has cured some cancers that are difficult to treat, and we want to know if we can do that for prostate cancer. Our hope is that this CAR T cell therapy can be a game changer for these patients."
CAR T cell therapy involves taking a patient’s immune cells, known as T cells, from the bloodstream. They are then reprogrammed in a laboratory to recognize and attack a specific cancer-causing protein, such as PSCA, and reintroduced into the patient’s bloodstream, where they get to work destroying targeted tumor cells.
City of Hope will manufacture the CAR T cells using in its own facility, the Cellular Therapy Production Center. This process includes a critical step: The patient’s T cells are reprogrammed with viruses engineered in another of City of Hope’s GMP facilities, the Center for Biomedicine & Genetics. These two facilities, coupled with its Chemical GMP Synthesis Facility, make City of Hope one of the few cancer centers in the world with the ability to produce GMP cellular, genetic and drug-based therapies for its patients.
City of Hope developed the CAR design in its own laboratory with a goal of finding the most effective and long-lasting CAR T cell to target PSCA.
"Developing a CAR T cell therapy for solid tumors is particularly challenging because they need to first reach the solid tumor and then survive in a harsh microenvironment that is filled with cancer cells and other cells that make up the tumor mass," said Saul Priceman, Ph.D., assistant professor in City of Hope’s Department of Hematology & Hematopoietic Cell Transplantation. "This CAR design has allowed for optimal cytokine production, which are chemical messengers that help enhance the anti-tumor activity of a CAR T cell, and destruction of prostate stem cell antigen (PSCA)-positive prostate cancers by the CAR T cells."
The trial is one of the first CAR T trials for prostate cancer in the nation. Since the late 1990s, City of Hope has been a leader in advancing CAR T cell therapies across a range of blood cancers and, in recent years, it has also opened trials for solid tumors, including brain cancer (glioblastoma) for adults and children, HER2-positive breast cancer that has metastasized to the brain and this prostate cancer trial.
City of Hope patents covering the PSCA CAR have been licensed to Mustang Bio.
City of Hope received a Challenge Award in 2013 from the Prostate Cancer Foundation (PCF) to support the CAR T cell therapy’s preclinical development, and in 2016 from PCF, which was matched by City of Hope, to fund the clinical trial. Research is also supported by a generous gift from Barbara and Zach Horowitz and Gary Marsh and Jody Horowitz Marsh.
The trial is part of City of Hope’s T Cell Therapeutics Research Laboratory, which currently has 20 open CAR T and T cell clinical trials.