Tag: kan-101

The rarest type of celiac

Update on the KAN-101 drug trial and why it’s no fun to be unusual sometimes.

I don’t qualify for the KAN-101 celiac drug trial. Since traveling to Miami to undergo the screening, I waited for confirmation of my Sept. 8 infusion appointment, 21 days after which I would, in theory, be able to eat gluten (bread!) with no ill effects for an as-of-yet-undetermined mount of time. When I saw the doctor’s cell number on my list of missed calls, I got excited. Very. Excited.

Dr. Saltzman’s voicemail, however, gave me pause: “I need to talk to you about your bloodwork.” No one wants that call from a doctor. I called him back and he gave me the not-great news: While otherwise healthy, I have the wrong celiac antigen in my blood and do not qualify for the trial. Which also means if and when this drug gets approval, it probably won’t work for me. The conversation went something like this:

Doctor: No one is more disappointed about this than I am.

Me: Oh, I highly doubt that.

Then I hung up the phone and cried. The Gabber office is about as big as a closet, so my staff had already figured it out. And yes, I know people have far worse health problems than “can’t eat bread,” but that does little to help my particular disappointment.

The wrong antigen — HLA-DQ8 — is uncommon in people with celiac. Really uncommon. My friend, colleague, and scientist-by-training Jen Ring explained it all to me in gentle, no scientist terms. The long and short of it is this: Five percent of celiacs have HLA-DQ8. As only one percent of the population has actual celiac, that means I have something that impacts five percent of one percent of the population, or: one-half person per thousand has the same genetic makeup of celiac and antigens.

This should have shocked me. Years ago, I learned I didn’t have the same RH factor as either of my parents. Rare, but not impossible. This, incidentally, prevented me from getting a specific treatment for an immune disorder (doctors now believe my undiagnosed celiac may have triggered that disorder) so instead of getting drug therapy, doctors removed my spleen.

And *why* did my celiac go undiagnosed? Because, friends, I have silent celiac, which — you guessed it — doesn’t happen that often. I didn’t have traditional symptoms.

The moral of this story? I really should look into PowerBall as a career strategy.

#BecauseGluten: A drug to treat celiac?

I’m part of the first clinical trial for a drug that will treat celiac and let celiacs eat gluten

Ever since my December 2016 celiac diagnosis, I’ve longed for the day I could eat gluten again. If you’ve slogged through this gluten-free journey from the beginning, you realize that getting a celiac diagnosis changed my life.

See, I didn’t exhibit the typical signs of celiac. When I ate bread, my stomach was fine. I didn’t have what we celiacs politely refer to as “gastrointestinal distress” and also, in a kick in the ass from karma, I loudly and proudly scorned the gluten-free movement sweeping America.

I did have severe anemia and osteoporosis, and my doctors found that peculiar and alarming for an otherwise-healthy 43-year-old. My regular doctor referred me to a hematologist who referred me to Dr. Abithitch Patil, a gastroenterologist who exhibited far more patience with me than I deserved. Five days before I turned 44, Dr. Patil diagnosed me with celiac.

Happy birthday to me.

I stopped eating gluten on January 1, 2017. While I’m grateful to Dr. Patil for his diagnosis — I do have more energy and my bones aren’t crumbling to dust anymore, which by and large makes me happy — not a day goes by that I don’t resent my gluten-free bread and pasta. Yes, food chemistry’s come a long way but trust me, not far enough.

I have coped in various ways, not all of them healthy. I’ve gained almost 60 pounds I cannot seem to shake. I will smell bread when it comes to the table at a restaurant. Going out to eat is actively stressful. I have many thoughts about the ways the gluten-free movement has helped and hurt celiacs. I have investigated almost every gluten-free product available (see: gaining 60 pounds.) I’ve created workarounds for baking without gluten. I scour the celiac.org website in search of news about treatments on the horizon. I’ve signed up for every trial I’ve seen in the past almost-four years and have qualified for none of them.

Until now.

Kanyos Bio, a biotech company that has found a way to fidget with T-cells, has a drug that’s progressed to trials on humans. When Dr. Saltzman called me to tell me I’d been approved for the study, I had cautious optimism. It took me a few weeks to decide to try it, and after much deliberation, I decided to proceed. Monday I traveled to Miami for a screening to ensure I checked all the boxes. Here’s what I learned about the KAN-101-01 study.

After a few phone conversations with Dr. Saltzman about the study, we reviewed everything in person. He took my medical history, and his staff drew blood, took urine, and did an EKG. We’re waiting on my medical records from my gastro to proceed, but I have the infusion date tentatively set for Sept. 8.

Here’s what I learned, in no particular order:

1. While I am either the first or second celiac in the study to get the infusion, they have given this to non-celiac adults in much higher dosages. One person (I believe) had slight gastrointestinal distress, but, again, this is at much higher doses than what I’ll get. Non-human primates tolerated the drug well, overall. 

2. My phase — Phase A — is what they call “open-label,” which means no one gets a placebo. 

3. The drug will alter the part of a celiac’s T-cells that cause the reaction that takes place when we consume gluten. The rest of the T-cell remains intact.4. The infusion itself should take no more than 30 minutes. I will spend the night at the facility and they’ll take my blood an insane number of times and make sure I’m not having any reactions. This is the only infusion I will receive.

5. I’ll return once a week over the following 21 days. Day 1 is a 24-hour stay. Days 4, 7, and 21 are shorter visits not unlike a doctor’s visit.

6. On Day 22, I am released from the study and should be able to resume a normal diet, gluten and all. They do not know how long the efficacy of the drug will last; indications point to anywhere from 6-12 months. 

They have several sites around the country; I am one of three celiac patients in Phase 1A at this location. They need more celiacs; getting people to travel to sites during COVID-19 has slowed the trial. 

The study still needs volunteers who have a celiac diagnosis via biopsy and blood. Here’s more information.

Finally, I’ll chronicle how it goes as I go through the trial — and what it’s like afterwards. Search this blog for #becausegluten to find more entries about my journey with celiac.