Atlantic Health System is conducting a new Phase II clinical trial involving CAR T-cell therapy at Morristown Medical Center. One of a handful of sites across the U.S. involved with the study done on an outpatient basis, the study sponsor is Juno Therapeutics, Inc (Celgene). Mohamad Cherry, MD, a nationally known expert at treating and researching blood-related cancers, such as lymphoma, serves at the study’s principal investigator. Medical director of the Atlantic Health System Cancer Care operation, he is a triple board-certified internal medicine, hematology and medical oncology specialist.
CART T-Cell Treatment
In CAR (chimeric antigen receptor) T-cell therapy, immune cells known as T cells are removed from the patient’s blood and altered in the lab to have specific receptors (chimeric antigen receptors) on their surface. These receptors can attach to proteins on the surface of lymphoma cells. The T cells are then multiplied in the lab and infused back into the patient’s blood, where they seek out the lymphoma cells and launch a precise immune attack against them. Both the currently approved lymphoma CAR T-cell treatment and treatments in clinical trials do not require that the patient be hospitalized while receiving treatment CAR T-cell therapies are designed for patients whose lymphoma has relapsed.
The Problem: Non-Hodgkin’s Lymphoma
Non-Hodgkin’s lymphoma is not just one disease; there are 60 subtypes of this blood cancer, which are either slow or fast growing. Different treatments are generally used for each subtype.
Lymphoma generally develops in the lymph nodes and lymphatic tissue found in organs such as the stomach, intestines or skin. In some cases, non-Hodgkin’s lymphoma involves bone marrow and blood. Approximately 85-90% of non-Hodgkin’s cases are B-cell lymphomas: they start when B lymphocytes (B cells), which produce antibodies to help fight infection, undergo a change (mutation) in a lymph node or other location in the lymphatic system. These abnormal lymphocytes accumulate and form tumors. If non-Hodgkin’s lymphoma isn’t treated, the cancerous cells crowd out normal white cells (immune cells known as leukocytes), and the immune system can’t guard against infection effectively.
The present clinical trial, an open-label (all patients receive the study medication), multicenter, Phase II study in an outpatient setting, seeks to determine the safety, pharmacokinetics (the way the drugs move inside the body), and efficacy of CAR T therapy in patients who have relapsed from, or whose disease is resistant to (refractory), two lines of immunochemotherapy for aggressive B-cell non-Hodgkin’s lymphoma. Study participants are followed for up to 2 years. See more about the study here.
The Investigational Product: JCAR017
The study is assessing the safety and antitumor activity in adult patients with relapsed or refractory B-cell non-Hodgkin Lymphoma when administered with lisocabtagene maraleucel (JCAR017) in the outpatient setting. Upon successful product generation of lisocabtagene maraleucel, subjects will enter the treatment phase of the study. Treatment will include lymphodepleting chemotherapy followed by lisocabtagene maraleucel administration. Subjects will then enter the post treatment follow-up phase of the study sand will be followed for approximately 24 months for safety, disease status, health-related quality of life and survival. Long-term follow-up will continue under a separate long-term follow-up protocol, per health regulatory authority guidelines, currently up to 15 years after the last lisocabtagene maraleucel administration.
Dr. Cherry commented, “A type of immunotherapy for lymphoma known as CAR T-cell therapy has generated a great deal of excitement within the medical community, because it involves using a patient’s own immune cells to attack their cancer,” said Dr. Cherry. He continued, “Two types of CAR T therapy are FDA-approved (tisagenleleucel or Kymriah and axicabtagene ciloleucel, or Yescarta) for certain types of advanced recurrent lymphoma. Other CAR T-cell therapies for non-Hodgkin’s lymphoma, including the one we are testing, are now in clinical trials.”
Atlantic Health System Cancer Care
Atlantic Health System Cancer Care offers an unparalleled network of cancer specialists and resources for more than 6000 patients annually through its flagship Carol G. Simon Cancer Center at Morristown and Overlook medical centers, as well as its comprehensive oncology programs at Chilton, Hackettstown and Newton medical centers. Atlantic Health System Cancer Care is the lead affiliate of Atlantic Health Cancer Consortium (AHCC) – the only New Jersey-based National Cancer Institute (NCI) Community Oncology Research Program (NCORP). The NCORP develops and implements NCI cancer prevention, screening, care delivery, and treatment studies with leading healthcare systems across the state. With more than 250 cancer specialists, all five hospitals and Atlantic Medical Group are designated Blue Cross Blue Shield ‘Blue Distinction Centers’ and have been recognized nationally for the role in advancing the fight against cancer. Morristown, Overlook, Chilton and Newton medical centers earned the coveted American College of Surgeons Commission on Cancer Outstanding Achievement Award and earned Three-Year Approval with Commendation. U.S. News & World Report has ranked Atlantic Health System hospitals as high performing in colon cancer surgery, lung cancer surgery, neurology and neurosurgery, and pulmonology. Atlantic Health System Cancer Care is affiliated with the Translational Genomics Research Institute (Tegan) of Phoenix, Arizona, and together they have launched the Breakthrough Oncology Accelerator, a pioneering research and clinical collaboration designed to improve patient access to the most innovative and sophisticated therapies for cancer.
Mohamad Cherry, MD,
Call to Action: Do you or a loved one have a Non-Hodgkin’s Lymphoma diagnosis? If you are in the New Jersey area, considering learning more about Atlantic Healthcare System.