Cancer patient finds hope – and remission – in CAR T therapy

Cancer patient finds hope – and remission – in CAR T therapy

When Novartis announced that the U.S. Food and Drug Administration (FDA) had approved Kymriah, the first chimeric antigen receptor T cell (CAR T) therapy, for the treatment of patients up to 25 years of age with a form of leukemia, it was a breakthrough for precision medicine.

The therapy uses Cell Therapy Systems (CTS) Dynabeads technology, developed by Thermo Fisher, to activate and expand T cells that have been genetically engineered to recognize and fight 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.

Life in the Lab: At what stage in your battle with cancer did you first learn about CAR T cell therapy?

Nicole Gularte: After a relapse in 2014, my doctors at the University of Stanford told me that I would need a transplant and that I’d be looking at 3-5 more years of additional treatment with a lot of side-effects and a low percentage of success. I kept pushing because there just had to be another option, and that’s when they mentioned CAR T.  But they told me that I wouldn’t live to see CAR-T treatments reach clinical trials and not to think about it because it would be a waste of my time. I left the hospital vowing to do my own research, and, in the meantime, I took part in a clinical trial for an antibody called Inotuzumab. Initially the treatment worked, but, more importantly, it served as a bridge to getting to CAR T.

LITL: So, if you considered it a bridge, does that mean you knew Inotuzumab was likely not a long-term solution?

NG: Yes. We knew Inotuzumab would likely put me in remission overnight, but we also knew that the antibody lacked the receptor that stays on to target and kill the cancer cells. So, despite being in remission, we knew the cancer would come back. But it bought me time and during that time, I pushed myself to pursue CAR T because I actually realized new drugs could work, and with far less toxicities. Until that point, my chemotherapy treatments were doing cumulative damage to my body, and I still suffer from side-effects.

LITL: Inotuzamab had no long-term side-effects?

NG: No, there are no long-term side-effects from Inotuzumab. I went into remission immediately after getting Inotuzumab but didn’t lose my hair or nails and didn’t feel sick. This experience gave me confidence and hope for the CAR T therapy.

LITL: And you had to cross the country to be in position for a CAR T trial, correct?

NG: Exactly. When I was first in remission from Inotuzumab in 2014, I called the University of Pennsylvania, which had a CAR T trial on hold, but I had a strong feeling that it would eventually come back because of the initial studies and the success rates. So UPenn granted me an appointment and although they knew I would eventually relapse, I was healthy at the time. They collected and froze my cells for when either the FDA lifted the hold on the study or I relapsed, which is what I needed to do to qualify for the study.

LITL: And what was it like for you to play the waiting game before you finally qualified for the CAR T trial?

NG: For two years, from 2014-2016, I traveled, shared my story and raised awareness while I was getting treatments. I had relapsed several times in my eyes and the leukemia had spread into my spinal fluid which kept me from being qualified for the study. And even though I was happy and still wanted to fight, the combination of chemotherapy that was injected in my spine every day and radiation was toxic, and it was diminishing my quality of life. That’s when I decided to go on palliative care and stop treatment. When they gave me 3-5 weeks to live, I decided to start planning my funeral. And since I was never baptized, my family and friends arranged for my baptism. I lived those weeks thinking they would be my last.

LITL: And then what happened?

NG: Miraculously, days before I was supposed to be dead, I had a final check-up and although the cancer didn’t go away, my blood was good and the leukemia was no longer detected in my spinal fluid which qualified me for the study. The next week I flew out to UPenn and got the treatment. The experience was amazing and within 28 days, my leukemia was gone. It was crazy because I went from having it spread to my eyes, my spine, my lymph nodes and my bone marrow to it being gone.

LITL: How are you feeling today? And what’s next for you?

NG: Last October, I had my annual checkup, which confirmed that I have no leukemia cells anywhere. I’ve also become very involved with the Emily Whitehead Foundation and was honored to be a speaker at the inaugural gala, which included more than 30 CAR T survivors – all children, aside from me. After that event and my clean checkup, I’ve made my purpose in life to be a voice for children with cancer, and I’m now launching a west coast operation of the Emily Whitehead Foundation.

To learn more about Nicole Gularte’s story, visit her blog: The Inspired Hero – Leading The Way With Immunotherapy.



Fighting For A Cure: A Friends Perspective



Kelly Marie Schwerin has been one of many friends who witnessed the chaos, struggle, and perseverance throughout my six year battle.  When I returned from Philadelphia from my CAR T Cell journey, it was Kellys birthday.  On October 26, 2016 this is what she wrote:

You touched down at the airport last night as the clock ticked my birthday. I can’t help but imagine how YOU are actually the Birthday Girl. I’ll GLADLY share October 5th with you. For on your fight for a cure, THIS is the day you return to your home in California. After multiple medical ‘death sentences’, you have been released from your struggle by diligent, unrelenting, Science. YOU made this happen. YOU fought for your place in this world. You never wavered. You never gave up hope. You DEMANDED your right to access CarT-Cell therapy, and you will now be the case study for the expansion of that study. You didn’t just save your own live. You created an entirely new group of standards for future participants. Yes, you fight for the cure on a large scale. But your individual fight for YOUR CURE has opened the door for countless others. YOU took one HUGE GAMBLE. You turned down a perfect bone marrow transplant match. You did it because you believed in what they were doing in Philadelphia. You took the ULTIMATE leap of faith. And in doing so, you have opened the door to save countless lives beyond your own. So I am BEYOND proud to share this day, my birthday, with you. In fact, I’m lucky in that YOU share it with me. I love you.        


Miracles at Penn Medicine

I completed my CAR T Cell Treatment on October 4th 2016 and five days later I was declared cancer free!  In fact, my tests showed I am in the deepest remission possible.

I was the first adult to turn down a 10/10 bone marrow transplant so I could allow myself to relapse, thus qualifying for the trial. It was a tough battle to get into the trial at Penn due to active CNS involvement for over two years, but I fought hard and in every possible way.  My efforts paid off because I will be giving a speech for The Parker Foundation at UPENN on October 25th, 2016!

I have photos with Carl June, Bruce Levine, and Don Siegle below.  I’m looking forward to speaking at the event!  I will have an update ASAP!

[Photo:  Myself, Dr. Bruce Levine, and , Dr. Don L Siegel. This was my first day of T cell transfusion].

[Photo: myself and Dr. Don Siegel. Photo was taken in their new lab which is also where Joe Biden had his photo taken for the cancer moonshot]

[Photo:  Dr. Carl June, myself, and Dr. Don Siegel.  Map behind us says, “Where in the World Is Carl June”]