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CAR T-Cell Therapy

A cancer diagnosis is a life-changing event. Early diagnosis is crucial in achieving remission and increasing survival rates. There are new treatment options beyond chemotherapy and radiation that have shown very promising results with patients during clinical trials. A new branch of treatments called immunotherapies use a patient's own immune system to fight the disease.

Cancer can be misdiagnosed for a number of reasons. For instance, the symptoms associated with certain cancers can be similar to those of other ailments. It is important for patients to note, however, that a doctor's misdiagnosis does not necessarily present grounds for a lawsuit. In order to have a valid medical malpractice lawsuit, the patient must be able to prove that the doctor who misdiagnosed their illness acted negligently. For a doctor to have acted negligently, they must have failed to take the steps that another competent medical professional in the same field would have taken when making a diagnosis.

Patients may have grounds for a medical malpractice lawsuit if their cancer was misdiagnosed due to any of the following:

  • The doctor ordered the wrong tests
  • The test results were misread
  • The doctor failed to order the appropriate tests based on the symptoms the patient was experiencing
  • Failure to follow-up
  • A tumor was misdiagnosed as benign

Although any type of cancer can be misdiagnosed, the more common examples of misdiagnosis occur in cases of:

Early diagnosis of cancer is usually critical because the earlier a cancer is diagnosed, generally speaking, the greater the chance of a cure and improved long-term survival. The statistics in this regard have improved dramatically over the past decades as new and better therapies have been developed and implemented by oncologists throughout the world.

What Is Adoptive Cell Therapy?

One type of immunotherapy called adoptive cell therapy (ACT) involves using a patient's own immune cells to recognize and kill cancer cells. Specifically, T cells are extracted from a patient's blood and genetically engineered with to produce artificial, or chimeric, antigen receptors specific for a particular cancer-associated protein (antigen), which allow the T-cells to recognize a specific antigen on tumor cells. The T cells are then known as chimeric antigen receptor (CAR) T-cells. The CAR T-cells are then reproduced in the lab until they number in the billions and are subsequently infused back into the patient's bloodstream where they again multiply in number. The CAR T-cells are then able to recognize and kill the cancer cells that have the targeted antigen on their surface. These CAR T cells remain in the body and protect against recurrence.

Clinical Trials

CAR T cell therapy has only been used in clinical trials thus far, but with very promising results. If you are interested in participating in a clinical trial visit https://clinicaltrials.gov/. The website is an investigational and research tool for any disease including cancer. The first trials focused on blood cancers, including leukemia and lymphoma. These trials have used T cells engineered to target the CD19 antigen, which is present on the surface of nearly all white blood cells called B cells, both normal and cancerous. Leading bio-technology firms have achieved incredible results in recent clinical trials.

  • In a study conducted by Novartis published in the New England Journal of Medicine in October 2014 in 27 of the 30 (90%) patients with Acute lymphoblastic leukemia (ALL) all signs of cancer disappeared (a complete response) after CAR T-cell therapy. These patients had previously relapsed multiple times or failed to respond to standard therapies. According to the lead investigator of the study, Stephan Grupp, M.D., Ph.D, normally there are no viable treatment options for patients whose cancers return after standard treatment such as intensive chemotherapy or a stem cell transplant. 19 of the 27 patients with complete responses have remained in remission.
  • In December 2014 researchers at Juno Therapeutics reported at the American Society of Hematology (ASH) meeting that in a clinical study 24 of 27 adults with refractive acute lymphoblastic leukemia (ALL) achieved remission after treatment with their CAR T-cell therapy and six patients were cancer free for more than a year. ALL is exceedingly difficult to treat and progresses rapidly when it becomes refractory or resistant to treatment; most patients die within a few months. Michel Sadelain, a co-founder of Juno said "This response rate is unprecedented for patients who had stopped responding to all other treatments.”
  • A trial by the National Cancer Institute, Pediatric Oncology Branch published in the Lancet Journal in October 2014 treated children with ALL using CAR T. 14 of the 20 patients had a complete response; 12 of whom had no evidence of leukemic cells in their bone marrow after treatment. 10 of those 12 have gone on to receive a stem cell transplant and remain cancer free.
  • 14 of 16 patients with relapsed or refractory B cell acute lymphoblastic leukemia (B-ALL) had complete responses from the CAR T cell therapy-in some instances after as little as 2 weeks- according to a study published in the Journal of Science Translational Medicine in February of 2014 conducted by the Memorial Sloan Kettering Cancer Center. 7 of those patients who were eligible went on to receive stem cell transplants and remained cancer free.
  • The majority of patients in a trial done by the National Cancer Institute published in the Journal of Clinical Oncology in February 2015, with diffuse large B-cell lymphoma (DLBCL) and had either complete or partial responses to the CAR T cell therapy. 4 of the 7 evaluable patients with chemotherapy-refractory DLBCL achieved complete remission. “Our data provide the first true glimpse of the potential of this approach in patients with aggressive lymphomas that, until this point, were virtually untreatable,” Dr. James Kochenderfer, the lead researcher said.
  • While Juno’s and Novartis’ most advanced CART programs treat patients with ALL, Kite Pharma has been making progress against another difficult to treat blood cancer, non-Hodgkin lymphoma (NHL). Its CAR T therapy produced four complete remissions in a Phase I study of seven patients with NHL. On April 19, 2016 at the American Association of Cancer Research (AACR) Annual Meeting Kite presented updated results from its clinical trial treating patients with chemo-refractory, aggressive NHL. The CAR T produced an objective response rate of 71% and a complete response rate of 57%; three of the patients had an ongoing complete response to the therapy ranging from six to nine months "The data reported today are important because refractory DLBCL [the most common form of NHL] is incurable. Median survival for these patients is short and there is no standard therapy," noted Ronald Levy, M.D., Professor of Medicine and Director of the Lymphoma Program at Stanford University School of Medicine and Associate Director of Translational Science for the Stanford Cancer Institute. He continued "Adoptive transfer of engineered T cells has the potential to become standard of care for patients with refractory NHL in the near future." Kite is on track to file for FDA approval of its CAR T by the end of this year.

Possible Side Effects of CAR T-Cell Therapy

The most common and serious side effect associated with CAR T-cell therapy is cytokine-release syndrome (CRS). The re-infused CAR- T cells release cytokines, chemical messengers that help the T cells execute their duties. In cytokine-release syndrome, there is a very large and rapid release of cytokines into the bloodstream, which can cause dangerously high fevers and steep drops in blood pressure. Patients with the most widespread disease prior to receiving the CAR T therapy were more likely to experience severe cases of cytokine-release syndrome. The symptoms experienced by most patients, are mild enough that they can be managed with standard supportive therapies, including corticosteroids. Drugs, such as etanercept (Enbrel®) and tocilizumab (Actemra®), used to treat inflammation were also effective at treating cytokine release syndrome.

The Future of CAR T-Cell Therapy

Many of these therapies are receiving orphan or breakthrough status from the US Food and Drug Administration (FDA), leading to accelerated regulatory review. In November 2014, the FDA granted orphan status to Juno’s JCAR015. Kite’s KTE-C19 for refractory aggressive NHL also recently received the designation from both the FDA and the European Medicines Agency; the University of Pennsylvania /Novartis’s CTL019 for ALL received breakthrough status last July.

Philip Greenberg, a Juno researcher and the head of immunology at Seattle’s Fred Hutchinson Cancer Research Center, explained that they have identified an antigen, WT1, that may provide a way for re-engineered T-cells to fight acute myeloid leukemia (AML), mesothelioma, and other cancers. The re-engineered cells are T-cell receptors (TCRs) and differ from CAR T cells because they are not chimeric or artificial, rather the genes are fully human, which may make them less liable to cause dangerous immune side effect. TCRs also have the ability to target proteins that are not merely on the surface but actually inside cancer cells, which may make them effective in treating a wide variety of cancers. NCI researchers have also reported positive results from a trial using donor CAR T cells, rather than the patient's own T cells to treat leukemia and lymphoma.

T cells may be engineered to attack pancreatic cancer in the near future. Pancreatic cancer is exceedingly difficult to treat and the prognosis is normally very poor. It was also considered difficult to treat with engineered T cells because it does not produce many unique antigens for the T cells to attack. However, Juno's Phillip Greenberg re-engineered T-cells to attack mesothelin, a protein that’s over-produced in the most pancreatic tumors. While mesothelin is also present in normal cells, in animal trials, the T-cells they developed only briefly remained in the normal tissues and didn’t harm them, rapidly traveling to the tumor cells. They plan to start human trials by the end of the year.

Unfortunately, life-changing therapies like this too often fail to be implemented in a timely fashion as there is a delay or failure to make a proper diagnosis.

Call Our Firm Today

If you or someone you love suffered further illness due to a physician's failure to properly diagnose cancer, you may be able to file a medical malpractice lawsuit to recoup damages. For a free, no obligation consultation call, 212-406-1700 or contact us online. Queller, Fisher, Washor, Fuchs & Kool will review your claim to see if our medical malpractice lawyers may be able to help you.

New York places a time restriction on how long an injured patient can file a lawsuit, known as a statute of limitations. If the statute of limitations expires before a victim files a claim, they may permanently lose their opportunity to recover compensation for the pain and suffering they were forced to endure. In New York, the statute of limitations for a medical malpractice claim is generally 2.5 years, if you believe your doctor should have suspected cancer, but your diagnosis was delayed do not hesitate to call us.

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