{"id":4672,"date":"2016-08-04T00:00:00","date_gmt":"2016-08-04T06:00:00","guid":{"rendered":"https:\/\/www.uchealth.org\/today\/2016\/08\/04\/target-cancer-uch-prepares-to-join-national-immunotherapy-trial\/"},"modified":"2022-05-17T13:11:10","modified_gmt":"2022-05-17T19:11:10","slug":"target-cancer-uch-prepares-to-join-national-immunotherapy-trial","status":"publish","type":"post","link":"https:\/\/www.uchealth.org\/today\/target-cancer-uch-prepares-to-join-national-immunotherapy-trial\/","title":{"rendered":"Target cancer: UCH prepares to join national immunotherapy trial"},"content":{"rendered":"
<\/div>

A clinical trial set to launch at the University of Colorado Cancer Center will test a therapy designed to fire the body\u2019s natural defenses against a deadly blood cancer.<\/p>\n

The target is acute lymphoblastic leukemia<\/a> (ALL), a cancer that strikes the lymphocytes, which are immature white blood cells in the bone marrow. It most often is treated with chemotherapy, drugs that target specific genetic mutations, and stem cell bone marrow transplants. Children have the greatest chance of surviving the disease. However, for some ALL patients the available treatments fail.<\/p>\n

In the past, these patients had little hope. But the multicenter trial in which the Cancer Center is participating and other efforts around the country could change that. The weapon being tested is a key building block of the body\u2019s immune system: T- cells. Rapidly dividing malignant cells in ALL and other cancers can deceive and overwhelm T-cells and their ability to kill the invaders. In a new stratagem, clinicians harvest T-cells from the patient\u2019s body, genetically modify them to recognize specific proteins produced by the cancer cells, grow them by the millions and infuse them back into the body.<\/p>\n

The T-cells, now equipped with disease detectors called CARs (chimeric antigen receptors<\/a>), set out to search and destroy the cells with the protein they have been programmed to recognize and to signal other T-cells to join the attack. The method is akin to a \u201csmart bomb\u201d that devastates an enemy while minimizing collateral damage, said Brian Freed, PhD, executive director of ClinImmune Labs<\/a>, a School of Medicine-associated biotech facility on the Anschutz Medical Campus that is building the infrastructure to grow and store genetically modified cells designed to fight cancer and other diseases.<\/p>\n

\"\"
School of Medicine hematologist Enkhee Purev is principal investigator for the Juno Therapeutics trial of CAR T-cell therapy for adult patients with acute lymphoblastic leukemia.<\/figcaption><\/figure>\n

Taking aim<\/strong><\/p>\n

The Cancer Center will recruit patients from anywhere in the country for a trial sponsored by Seattle-based Juno Therapeutics. It targets adult ALL patients whose cells express a protein called CD19 that is very commonly present in B-cell lymphomas<\/a>, including ALL, said principal investigator Enkhee Purev, MD, PhD, assistant professor with the Division of Hematology in the University of Colorado School of Medicine\u2019s Department of Medicine. The CAR T-cell treatment probably represents the last hope for adult patients who have exhausted the standard treatment options, she said.<\/p>\n

\u201cThese are patients who have gone through many treatments, including chemo and transplants,\u201d Purev said. She said without therapy they would typically have only two or three months left to live.<\/p>\n

Past CAR T-cell studies, though limited to a relatively small number of patients, give reason for optimism. The National Cancer Institute<\/a>, for example, acknowledges the need for further research, but notes that many ALL patients in the trials have had their cancers disappear entirely and have remained cancer-free after CAR T-cell treatment.<\/p>\n

The approach has \u201cenormous potential,\u201d said Jonathan Gutman, MD<\/a>, a colleague of Purev\u2019s and associate professor in Hematology.<\/p>\n

\u201cWe\u2019re seeing on the order of 90 percent of patients with complete disease control. That\u2019s an unbelievable thing to see,\u201d Gutman said. He noted that the new treatment offers hope not only for patients with diminishing prospects of recovery \u2013 most notably those adults in whom ALL recurs \u2013 but also as a possible future alternative for those who now go through difficult rounds of chemotherapy and transplants to eliminate the disease.<\/p>\n

\"Jon
Purev\u2019s colleague, Jon Gutman, believes immunotherapy has enormous potential for treating ALL and other cancers.<\/figcaption><\/figure>\n

There are provisos. Gutman stressed that immunotherapy research is still in its relative infancy. Even if it proves its mettle, he added, it will be challenging to spread it quickly to large numbers of patients because of the complicated technical and infrastructure requirements.<\/p>\n

\u201cIt\u2019s a complex and sophisticated treatment, and that raises questions about its broad applicability,\u201d Gutman said.<\/p>\n

The treatment also demands providers with the experience to manage the most serious side effect of the treatments, such as cytokine release syndrome (CRS) and neurotoxicity. The problem occurs when the cancer-seeking T-cells release storms of cytokines, which are molecules that T-cells use to signal other cells and can trigger inflammation in the body. Providers treat CRS and neurotoxicity with an immunosuppressant medicine, tocilizumab, and with low-dose steroids at the first sign of fever.<\/p>\n

Preparing for battle<\/strong><\/p>\n

\"Clean
A clean room at ClinImmune Labs on the Anschutz Medical Campus. ClinImmune is preparing the infrastructure for growing cells for immunotherapy and getting ready to meet FDA requirements necessary to do so.<\/figcaption><\/figure>\n

The therapy itself is at this point \u201cvery expensive and labor-intensive,\u201d Purev said. It involves several steps taken over a period of weeks. Clinicians first draw blood from the patient and separate the T-cell lymphocytes, Purev said. These are genetically modified to recognize a specific cancer calling card \u2013 in the case of the Juno Therapeutics trial, CD19 \u2013 and then grown over a two- to three-week period to build sufficient numbers of attacking forces. At that point, providers infuse the fighting cells into the patient and later perform bone-marrow biopsies to determine if the treatment cleared the body of cancer cells.<\/p>\n

Purev said providers will probably recommend a bone marrow transplant for patients following CAR T-cell infusion treatments.<\/p>\n

For this trial, Juno Therapeutics will modify and grow the cells at its central facility, Purev said, then ship them back through ClinImmune. She, Gutman and Freed, however, are looking to build a home-grown cell-based therapy operation in the future.<\/p>\n

Grow your own<\/strong><\/p>\n

Outside ClinImmune\u2019s facility, which is part of CU\u2019s Gates Center for Regenerative Medicine<\/a> in the Biosciences 2 building, stands a 15,000-gallon liquid nitrogen tank. It supplies gas to a first-floor room with refrigerated units for storing cell samples. Up one floor are clean rooms, the \u201cclosed micro-environments\u201d necessary for growing re-engineered cells by the millions, Freed said.<\/p>\n

\"ClinImmune
ClinImmune Executive Director Brian Freed stands near some of the many liquid nitrogen-cooled containers used to store cells.<\/figcaption><\/figure>\n

\u201cWe technically can do the work now,\u201d Freed said. But the preparations also require meeting a host of FDA regulatory standards, he added.ClinImmune went through a similar process in 2012<\/a> when it became just the second public cord blood bank in the country accorded FDA licensure. The lab again will have to provide documentation of environmental monitoring, training, protocols, and equipment validation, Freed said, adding the regulatory work could be finished by the fall.<\/p>\n

Making that happen is a necessity, Freed emphasized, because with sufficient resources, the possibilities inherent in cell-based therapies are limitless. \u201cWe can find targets specific to any cell we want to remove,\u201d he said.<\/p>\n

Gutman agrees that the opportunities for immunotherapy research and development are widening. \u201cThe data has been good enough to get industry involved,\u201d he said.<\/p>\n

One doesn\u2019t have to look far to find evidence of that: Children\u2019s Hospital Colorado is part of a separate multicenter trial of a CAR T-cell therapy, sponsored by Kite Pharma, Inc., that also targets CD19. If these and other trials continue to show strong results, Gutman believes pharmaceutical companies will look to find partners like ClinImmune to take over the job of growing and storing reengineered cells. That, in turn, would encourage researchers on the Anschutz Medical Campus to develop their own cell-based therapies.<\/p>\n

Purev said the Juno trial is a very important step for UCHealth and its campus partners in strengthening its clinical and biotech base.<\/p>\n

\u201cWe are excited because this trial could open the door to future studies,\u201d she said. \u201cWe look forward to collaborating with other groups and learning to take care of patients on our campus with this new therapy.\u201d<\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

A clinical trial set to launch at the University of Colorado Cancer Center will test a therapy designed to fire the body\u2019s natural defenses against a deadly blood cancer. The target is acute lymphoblastic leukemia (ALL), a cancer that strikes the lymphocytes, which are immature white blood cells in the bone marrow. It most often […]<\/p>\n","protected":false},"author":2143,"featured_media":3059,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[5],"tags":[28,49,64,189],"class_list":["post-4672","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-innovative-care","tag-cancer-care-oncology","tag-cancer-treatment","tag-cancer-wellness","tag-immunotherapy"],"acf":[],"yoast_head":"\nTarget cancer: UCH prepares to join national immunotherapy trial - UCHealth Today<\/title>\n<meta name=\"description\" content=\"A clinical trial set to launch at the University of Colorado Cancer Center will test a therapy designed to fire the body\u2019s natural defenses against a deadly blood cancer. 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