T-Cell Journey

Exclusive:  Penn Patient Shares The Story Of Her CAR T Cell Therapy Journey

 

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When Reporting Clinical Trial Results Saved a Life – by Sense About Science USA

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Nicole Gularte, October 25, 2016

In June 2016, Nicole Gularte was ready to die. The 33-year-old tax accountant had relapsed from Leukemia several times since her diagnosis years earlier. She had lost her hair, could only see in black and white, and her knees hurt so badly that she could no longer turn to hiking and the beautiful vistas of Yosemite National Park for inspiration. Now, she turned her attention to making peace with death, getting baptized, and saying goodbye to her family.

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Cancer Patient Finds Hope and Remission in CAR T Cell Therapy – by PBS and Thermo Fischer Scientific

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Nicole Gularte (holding her bag of t-cells) with Don Siegel, MD, PhD, director of laboratory medicine and pathology at the University of Philadelphia’s Abramson Cancer Center; August 2014

When the U.S. Food and Drug Administration (FDA) announced its approval for use of a new immunotherapy in August 2017, it was a breakthrough for precision medicine. The immunotherapy, used to treat a form of pediatric leukemia, became the rst FDA- approved, commercially available chimeric antigen receptor T (CAR T) cell therapy.  The therapy uses GibcoTM Cell Therapy Systems (CTSTM) DynabeadsTM technology, developed by Thermo Fisher Scienti c, to activate and expand T cells that have been genetically engineered to recognize and ght cancers unique to each patient. This all starts with the patient’s own cells, which are infused back into them after the process is complete.
Nicole Gularte’s cells took this same journey, and today she remains cancer- free. But her road was far from easy. After being diagnosed with acute lymphoblastic leukemia (ALL) in 2010, and spending
the next six years in and out of cancer treatments, the novel precision medicine approach was her last hope: She was exhausted and had exhausted all options.
Gularte, 32, answered questions about her journey for Life in the Lab.

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CAR-TCR Asia Summit

Read the stories of CAR-T patients from around the world – by Hansen Wade

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Nicole Gularte – two weeks after completing her CAR T-cell trial at The University of Pennsylvania’s Abramson Cancer Center, October 25, 2016

Nicole began fighting for CAR T-Cell treatment in 2014 and it took over two years and half-a-dozen “no’s” before she was treated.

The last seven years has been a long battle full of challenge, risk, self advocacy, and research. Over the course of six years (2010 – 2016),
she have had six relapses and have participated in three clinical trials (two at Stanford and one at UPenn). Her last clinical trial at The
University of Pennsylvania (CAR T-Cell – Novartis CTL019) saved her life, and in October of 2016, she became a seven-time cancer survivor.

Today, she is an active patient advocate and keynote speaker.

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GE Reports – Cell Therapy:  GE’S BEST OF 2017 – 12 BEST STORIES OF 2017

Survivor: This Woman’s Battle With Leukemia Is Pointing The Way To The Future Of Healthcare – by Kristin Kloberdanz & Bruce Watson

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Gularte, next to University of Pennsylvania’s Dr. Carl June, a leading cancer researcher

In the spring of 2016, 32-year-old Nicole Gularte grew weak and lost her ability to see colors from her left eye. She knew that her leukemia had returned.

Gularte’s form of the disease was called acute lymphoblastic leukemia, or ALL. She had been in an exhausting on-and-off battle with cancer for six years, and she was desperate to avoid yet another debilitating round of chemotherapy. She wasn’t particularly thrilled when doctors told her they had gotten lucky and found two nearly perfect bone marrow matches. Long-term studies have shown that nearly half of leukemia patients who receive a bone marrow transplant die or relapse within two years.

The story of what she did next offers a fascinating look into the future of cancer treatment. She rejected the transplant and opted to let the relapse of her ALL take full hold. That allowed her to enroll in a clinical trial of a promising new cancer treatment called CAR T-cell therapy that was run by the University of Pennsylvania and Children’s Hospital of Philadelphia. “I called UPenn,” Gularte says. She made her circumstances clear to the doctors, telling them: “I’ve given up a 10-out-of-10 bone marrow transplant so I can relapse so I can qualify for your CAR-T trial.”

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GE Healthcare – Manufacturing medical marvels: How a new cell therapy platform helps scale up manufacturing to reach more patients

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GE Ventures annual investor meeting, San Francisco, March 7, 2017. From left to right: Diana Maichin, Nicole Gularte, and Holly Colbo

In August 2016, doctors gave 33-year-old Nicole Gularte three to four weeks to live.

She had relapsed with acute lymphoblastic leukemia (ALL) seven times over the last decade. ALL is a type of fast-moving blood cancer that causes the bone marrow to produce too many immature white blood cells, which can spread the disease to other parts of the body. If left untreated, ALL is deadly.

Nicole had exhausted all her treatment options – except one.

Her last hope was an experimental treatment known as CAR T-cell therapy.

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GE Reports – Cell Therapy

New Center Helps Scientists Reprogram The Immune System to Kill Cancer – by Tomas Kellner

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Nicole Gularte was 26 years old and straight out of graduate school when she was diagnosed with acute lymphoblastic leukemia, also known as ALL, in 2010. This type of fast-moving blood cancer causes the bone marrow to produce too many immature white blood cells, called lymphocytes, which can spread the disease to other parts of the body. If left untreated, it can turn deadly within months.

Determined to keep fighting, Gularte decided to try a different tactic: enroll in an experimental treatment known as CAR-T therapy, which uses her own immune cells that have been reengineered to find and kill the cancer.

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CAR T-cells – Promise and Peril of Cancers – Silver Bullet — by Unit Scientific and ProMab Biotechnologies

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ProMab Biotechnologies, Richmond, CA; from left to right, Matthew Dudley (cancer survivor), Nicole Gularte (CAR T-cell recipient), John Wu (Founder of ProMab), and Jenny Wu (daughter of John Wu); October 2017.

Unfortunately, a few years after a long ordeal with cancer, Ms. Gularte received the crushing news in 2014 that she had relapsed – once again she would have to fight for her life. This time though, she would make the life changing decision of choosing a newer and unconventional form of treatment. Under the care of Dr. Carl June at University of Pennsylvania, Ms. Gularte would undergo the same therapy that saved Emily Whitehead.

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WebMD: Nicole Gularte – by Brenda Goodman

“I Was Planning My Funeral. This Therapy Was My Last Chance”.

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Day 14 of CTL019 study at UPenn. Don Siegel, MD, PhD; Nicole Gularte, And Bruce Levine, PhD

I’d fought an aggressive form of leukemia for seven years. Chemotherapy and immunotherapy tamped it down, but it would come back– six times.

The last time, I had cancer in my liver, my eyes, my brain, and in my central nervous system. Every day, I was getting a painful procedure called a lumbar puncture where doctors insert a long needle between the vertebrae to pump chemotherapy directly into the spine.

I had more than 200 of those lumbar punctures. I was hurting. I just couldn’t do it anymore. I went into hospice and palliative care.

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HARD TO FATHOM – BY ROBERT URBAN

Johnson & Johnson Innovation

Johnson & Johnson Innovation’s, Dr. Robert Urban and CAR T-cell recipient, Nicole Gularte; March 2017

We all have expectations. We have dreams. Each day we rise to a set of promises about the weather or our schedules – perhaps to go to work, school or maybe to just take a day to relax. The ratio and intensity of these expectations shift as we move through the chapters of our lives. Thankfully, an increasing fraction of the world’s population has the resources and freedom to live in such a way. But for many, on some unplanned day, these daily rituals and expectations will be eclipsed by news of a life-threatening disease. In the mere moments required to utter and comprehend a “we are so sorry to have to tell you” diagnosis, we are transformed from an individual, a customer, a voter, a parent, son or daughter into a patient. Not just a patient, but one with a lethal disease.

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T-Cell Therapy Patient Story: Nicole Gularte – By Thomas Whitehead 

Emily Whitehead Foundation

Emily Whitehead Foundation’s, Jessie Ayoub (left) and Kari Whitehead (second from left) with T-cell patient, Nicole Gularte and friend (second from right), Lia Duncan (right)

Nicole Gularte is 33 years old and has relapsed with leukemia 7 times. Over the last couple of years she has been speaking in California about Emily’s treatment in between her own cancer treatments at Stanford. Nicole had her T-cells extracted, modified, and frozen awhile back in case she needed T-cell therapy. I had been messaging Nicole to encourage her to keep fighting.

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