Trial Report Plasma cell targeting with the anti-CD38 antibody daratumumab in ME/CFS -a clinical pilot study, 2025, Fluge et al

[Jaybee00]

“Protocol ver. 1.6: Amended treatment protocol; this will apply to four additional patients included in Q1 2025, as well as retreatment of one previously included patient with partial relapse. Patients will receive the first daratumumab subcutaneous injection at week 0. For patients with signs of clinical response after the first injection, a second injection will be given at 24 weeks, and a third injection at 48 weeks.

At week 10, if there are no signs of a clinical response, a second daratumumab injection will be given, and, subject to a clinical response, the third and fourth injection will be given at week 24 and 48. If patient experiences no response after the second injection, no further daratumumab will be given.”

Can be found here.

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@Jonathan Edwards does this amended protocol seem sensible to you?

If I recall correctly, you stated earlier (somewhere) that one initial dose of Daratumumab would be sufficient to deplete LLPCs. This protocol will only be given to several patients in the extended pilot project and it consists of only 3 injections at weeks 0, 24 and 48. For patients who don’t respond by week 10 an additional injection will be given then.

 

[someUsername]

Yes, you can improve well if you regularly work out. I was commenting on what the personal trainer said that he was surprised that you needed rest and couldn't repeat the workout without rest as a beginner and that you couldn't lift the same weight the next day.

A Personal Trainer would recognize this pretty soon and adjust intensity. But If I saw that I needed to decrease intensity for my client multiple times, and Training progress to be slow for multiple weeks/months, this would defenetly seem highly unusual.

A beginner usually makes very easy gains not only by gaining muscle mass but especially by improving brain - muscle coordination.


I tried to follow along on the discussion, but Its difficult for me to understand.
Under the hypotheses that dara workes in a subset (which is not clear yet because of N=10 and No Placebo), does this Not imply that it has to be some issues with plasma cells? And if so why does there not seem to be clear marker ? I think the responders Had somewhat normal markers right?

Sorry If this was answered before.

 

[Hutan]

We have moved and copied a number of posts about experiences of muscle fatiguability to a dedicated thread, so as to not divert the thread. Please do check the posts out here:
Muscle Fatiguability After Exertion

We have kept some of the initial posts on this topic on this thread so as to keep the point that muscle fatiguability is part of ME/CFS in this discussion.

 

[Jonathan Edwards]

@Jonathan Edwards does this amended protocol seem sensible to you?

I don't know enough about data on antibody profiles with Dara.
I am not sure what the reason for 24 and 48 weeks would be. These are relevant to rituximab because it takes approximately 24 weeks for B cell recovery but that is not relevant to plasma cell targeting where the recovery in antibody production is likely to depend purely on Dara half life, which may be about 10 days. Nobody knows why rituximab depletes B cells for 6 months as far as I know.

 

[tuha]

I dont know if I would call it muscle weakness or fatiguability. I think we have strength in our muscles but there is no stamina. And the strength is there only for a really short time. What is also bizzare that you can regulary exercise a muscle but you will improve very little stamina of that muscle.

I also think that it has nothing to do with PEM. I get PEM few times a year but these muscle problems are there every day.

I can walk 6000 steps a day but especially in my calfs I feel every day kind of muscle soreness but I think it's different from what I felt when I was healthy and I overexercised. I ask if it' s not the same feeling like by restless legs syndrome. And I have daily cramps in my calfs.

These muscles problems were always a big mystery for me. Before I was sportman and I often overexercised but the problems and feelings after overexercising in the muscles were different.