To Fight or Not To Fight

Things have changed since this morning. After receiving news that my cancer will come back (even if this new CAR T does work), I have decided to put an end to furthering treatment.

Besides having exhausted all of my energy and resources to fighting this cancer, I just cannot endure anymore of the emotional and physical pain associated with fighting and surviving – especially because I know what survivorship offers and truth is, the grass isn’t greener on the other side.

Today I was supposed to go to the hospital for chemo and another spinal tap proceedure, but I decided to cancel all appointments, procedures and chemo regimens. The scary reality and hard truth is that I’m tired of being a lab that. I’ve paid my dues and I just want to rest in peace 🧡

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CELL THERAPY

Survivor: This Woman’s Battle With Leukemia Is Pointing The Way To The Future Of Healthcare

Nov 22, 2017 by Kristin Kloberdanz & Bruce Watson

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.”

In cell therapy, doctors remove some of a patient’s T-cells, the immune cells that fight against infection, reprogram them to fight and kill cancer, then put them back into the patient. Developed by doctors at Children’s Hospital of Philadelphia, the treatment gained prominence after it saved a young girl named Emily Whitehead in 2012. It’s had a 93 percent success rate in trials with patients with advanced leukemia, but it’s still a very new type of therapy. A refined version of the treatment that saved Whitehead, now called Kymriah and made by Novartis, was the first CAR T-cell therapy approved by the FDA, which in August cleared it for use in children. In October, the FDA approved a second version of CAR T-cell therapy, called Yescarta and made by Kite, to treat b-cell lymphoma for adults.

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

Most other, similar versions of the treatments are still in the testing phase. But this new form of treatment is a welcome alternative to patients who, like Gularte, find chemo dismaying and bone-marrow transplants too uncertain. “I realized that if there was a chance of something better out there, I needed to research it and come up with my own decision,” Gularte says.

The University of Pennsylvania’s adult cell therapy trials proceeded haltingly until they gained momentum in 2016, just in time for Gularte. She gained admittance to the program, and on September 7, she received her modified T-cells. Doctors had previously removed them from her body, modified them with a virus to recognize her cancer, multiplied them and transfused them back into her body.

She spent the next few days wracked with 105.8 degrees Fahrenheit fever and suffering from several seizure-like episodes as the T-cells started fighting her disease. But her temperature soon lowered, and, on the tenth day, something surprising happened. Her eyesight, which had deteriorated during her fight with leukemia, returned.

“I was half blind in one eye, and totally color blind,” she recalls. “Then, while I was watching TV, I noticed that the girls on the screen had bright green skirts.” When she had her color vision tested, she scored 13 out of 15. Soon, her T-cell levels, which plummet when leukemia patients are battling the disease, returned to normal. She was released from the hospital.

A year later, Gularte’s T-cell activity is elevated, but she is still in remission. She’s become a passionate advocate for CAR T-cell therapy. The University of Pennsylvania’s cell therapy trial is one of more than 800 studies in gene and cell therapy currently underway globally. And based on the 80 percent complete remission rates of these trials, experts anticipate that cell therapy is poised to become a major means for fighting cancer.

Top: In 2016, Nicole Gularte entered a cell therapy trial run by the University of Pennsylvania and Children’s Hospital of Philadelphia with the hopes of fighting her acute lymphoblastic leukemia. It worked, and today her cancer is still in remission. Image credit: Nicole Gularte. Above: GE scientists and others are working to accelerate the manufacturing processes of such cell therapies at the Center for Advanced Therapeutic Cell Technologies in Toronto. Image credit: CCRM.

Tens of thousands of patients per year could be receiving the treatment by 2024, and by 2030, the cell therapy industry is expected to be worth an estimated $30 billion.

While these emerging therapies bring new hope, the process to manufacture them can be lengthy and expensive, and producing enough to meet potential demand is challenging. “Now we need to help make cell therapy affordable and scalable,” says Phil Vanek, general manager for cell therapy growth strategy at GE Healthcare Life Sciences.

GE’s cell therapy business and others are racing to provide technology and processes to make that happen. In collaboration with Center for Commercialization of Regenerative Medicine (CCRM) and the Federal Economic Development Agency for Southern Ontario, they’ve embraced a new cell therapy research and process-development facility called the Center for Advanced Therapeutic Cell Technologies, which officially opened this September in Toronto. Designed to help pharma companies, university researchers, startups and technology companies scale up manufacturing faster, the new center already employs a team of more than 30 biologists, virologists, and biomedical and other engineers, from both GE and CCRM.

“We’re transitioning into the future,” says Gularte. “It’s not just about traditional drug discovery anymore, it’s now about the innovative life sciences industry, and the ways that doctors are learning to work with the body. Cell therapy could potentially eradicate many diseases. I wanted to be part of that.”

T-Cell Therapy Patient Story: Nicole Gularte | Emily Whitehead Foundation

 

T-Cell Therapy Patient Story: Nicole Gularte

Written by Emily Whitehead Foundation co-founder and Emily’s dad, Tom Whitehead.

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.

On August 12th she messaged me that she was worn out, had stopped treatment three weeks earlier, and that her doctors had given her 4 to 5 weeks to live. She told me that this time her relapse was in her spinal fluid, which would disqualify her from the T-cell therapy trial, so she had contacted her doctors to tell them she was stopping all treatment. I asked Nicole what she had done since stopping treatment because I was getting strong feelings that she was going to get her modified T-cells. She told me that since stopping treatment she had been baptized and had attended several events where people prayed for her.

I told her that it was hard for me to explain, but just like when I knew Emily would survive her treatment, I had a very strong feeling that she would get her modified T-cells if she kept fighting. I explained to her that I have learned to pay attention to the whispers in my life and that if she would keep fighting we would do anything and everything to help her.

“I told her that it was hard for me to explain but, just like when I knew Emily would get through her treatment, I had a very strong feeling that she would get her modified T-cells if she kept fighting.” – Tom Whitehead

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“I told her that it was hard for me to explain but, just like when I knew Emily would get through her treatment, I had a very strong feeling that she would get her modified T-cells if she kept fighting.” – Tom Whitehead

Nicole messaged me not long after that and said ‘Thank you for inspiring me, I have now decided to get my blood checked one more time at Stanford’. She went the next day and that evening she and her mom called me crying and told me her blood came back cancer free. She went back to the doctor the next day and had a spinal tap…her spinal fluid came back clear of cancer. This meant that Nicole now qualified for the T-cell therapy clinical trial at Penn in Philadelphia, but she had lost nonrefundable flights because she was too sick to fly.

With help from some very special people, we were able to reach out to American Airlines and they donated a flight to get Nicole and her friend Janelle to Philadelphia so Nicole could get her T-cells. One of the doctor’s called me and said ‘Tom, I heard that you inspired Nicole, and I am amazed that she got results back cancer free.’ He said ‘I don’t know how to medically explain the clear blood test but I want you to know, I BELIEVE.’

Last month, Nicole received her modified T-cells and spiked a high fever due to the cytokine storm that can occur with this type of immunotherapy treatment (just like it did with Emily). She almost needed a ventilator but doctors administered tocilizumab (the same medicine that turned Emily around when she was so sick). It also worked for Nicole and she was feeling much better by the next day.

I received a message from Nicole when I was in Boston attending the International CAR-TCR Summit (a T-cell therapy conference). She told me that before she had the T-cell therapy, she had only been able to see in black and white in her left eye for the last two years due to leukemia cells in her eye…but that now she could see in full color! This was our first sign that the T-cells might be working. Nicole stayed in Philadelphia for several more weeks to recover and flew home to California earlier this week. On Thursday she received the news that her spinal fluid test came back cancer free. Then, on Friday, her doctors said her bone marrow was also free of cancer – the T-cell therapy worked! 

During Nicole’s time in Philadelphia, Kari happened to be speaking at a conference in Philadelphia, so she was able to meet and have lunch with Nicole and her friend Lia, and EWF board member Jessi Ayoub. Nicole, Lia, and Jessi also had a chance to attend Kari’s speech! You can follow Nicole’s journey on Facebook at Fighting Fire with Fire – Nicole’s Journey.

Kari and I receive calls and emails from patients from around the world more than once a week. We are working very hard to continue expanding the Emily Whitehead Foundation while we both work full-time jobs but there just never seems to be enough hours in the day! Talking with patients who need help now to survive always comes first. I hope to get the time to continue to update on other patients we are currently helping. Many patients still find out about these innovative treatments such as T-cell therapy too late.

We will continue to raise awareness for this treatment and help patients as much as we can. When Kari and I speak at events we always tell the story of how all of your prayers and positive thoughts helped our family get through Emily’s treatment. To continue growing our foundation we could use any help you can provide such as holding fundraisers and joining The Villagedonating, sharing your story, or sharing information from our website or these blog posts, so we can continue to reach other patients. Together we can make a difference!

For all the families who fought with us – we think of all of you every day especially those courageous warriors who cancer took from us. You inspire us to never stop trying to make a difference. I will continue to listen to the whispers and act on them in the hope that some day many more families will be changed for the better because their loved one survived just like our Emily.

We plan to continue sharing other patient’s stories here on our blog, including a patient who will receive the T-cell therapy this week!

Listen to the Whispers / We Believe!

~Tom