TNB-383B Phase I Trial

I recently enrolled in a clinical trial at Wake Forest Baptist Health.  A phase I trial to test TeneoBio’s TNB-383B. Before this, I spent several months on carfilzomib, dex, and cyclophosphamide.  Test results and bone marrow biopsy indicated I was relapsing.

TNB-383B is a BCMA x CD3 T-cell engaging bispecifc antibody being studied in relapsed or refractory multiple myeloma who have received at least 3 prior lines of therapy.

TNB-383B is being developed by TeneoOne through Phase 1. AbbVie holds the exclusive right to acquire TeneoOne and lead subsequent global development and commercialization of TNB-383B.

AbbVie, Inc. “TNB-383B.” AbbVie. Accessed November 24, 2020. https://www.abbvie.com/our-science/pipeline/tnb-383b.html.

I had one infusion of the drug almost two weeks ago. The first infusion required a hospital stay due to the potential for serious side effects, primarily cytokine release syndrome and tumor lysis syndrome. It sounds scarier than it was, in my case.
About two hours after the infusion of TNB-383B I began to experience an extreme skin sensitivity, aching joints — mostly knuckles and elbows, rigors, headache, and a fever of something over 103 degrees F.  I’m not sure what the ultimate high temperature was.  I had not known about rigors before this event.  I don’t think I was shivering as much as what I’ve heard others talk about.  I was extremely cold, and I think I was constantly begging for a blanket.  I don’t really remember everything!  I was aware at some point that they were talking about testing me for Covid-19, just to make sure that wasn’t the cause of the symptoms.  They were also giving me fluids and Tylenol.  I remember being wheeled to an isolation room, which was something they did as a precaution. In case I had Covid-19. My blood pressure also dropped about 30 points.  I had a rapid heart rate, too.  I heard a nurse talking about giving me morphine, which I declined.  I’m not sure why I did that.  Later I learned that morphine helps with rigors.
I could tell the efforts of the staff were beginning to be successful when I was no longer cold. Isn’t it weird that having a high fever would make me cold? Throughout the next few days, I was given fluids and Tylenol.
By the way, I was not positive for Covid-19.  And, the swab test is not as bad as the crybabies on TV have reported. :  )  I guess it’s all relative. If you’ve had bone marrow biopsies and bone fractures, no swab into the nasal cavity is going to bother you.
Next time, I’ll post some of the test results.

5 Comments

  1. JC

    Please keep us posted. Also about ready to start in BiTE trial, though a different one than you are doing. Did you consider CAR-T? Prayers for the best results!! Thanks

    • Beth

      I did consider CAR-T. At that time, there was not a trial close to home. I would have had to hang out in another city, in some lodging. I was also scared of cytokine release syndrome. I went ahead and did approved treatments until they failed. At this point, I have a few FDA approved treatments to turn to, and a few more trials (if this one doesn’t help).
      Which trial are you going to be starting?

      • JC

        I will be doing the Regeneron (hope I spelled that correctly) trial. It is a weekly infusion for the first 16 weeks, and then every other for another 24 weeks. Like you, my numbers said it was time to make a change-limited options left. I have been on venetoclax for almost a year, which I really liked, great QOL on that drug. Considered CAR-T, even turned down slot a year ago. I have done two SCT, so I wasn’t so concerned about the process of CAR-T, more how aggressive the MM can be after relapse. That said, if I didn’t get this BiTE slot, I would have done CAR-T if available and I qualified. If I remember correctly you also found out you had MM around the time I did, 2007? Best wishes for success, would be so wonderful if this clinical trial could be a gateway to help so many others.

        • Beth

          Hi JC,

          I found out I had MM in January, 2003. It took a few years to get to that diagnosis, too. I hadn’t felt right for a few years before that. It took one doctor who decided to run total proteins test.

          I was told today that I had a fantastic response after just one infusion of the trial drug. I really hope this can be something that will help a lot of people, and will produce long-lasting results with minimal maintenance.

          I hope you can get that slot! Stay in touch, ok? If you don’t have my email address, go to the contact page and send me a note. I’ll reply from my email address so you’ll have it.

          I’d like to find out more about the Regeneron trial.

          Take care,
          Beth

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