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

what is your take on the wording? does it imply the levels are similar or constant?
Don't know about the other antibodies but I'm pretty sure we've seen studies showing some fluctuating test results for the SARS-COV-2 antibodies including some decay over time. Given the duration of study an asymptomatic infection might also not be completely unlikely in a small subset of participants. So I would naively think "similar" levels is the best one could expect.
 
For the seven shot cohort, IGG didn’t decrease with the 3 additional shots (the yellow arrows). Any ideas about this? Maybe Daratumumab can’t deplete any more cells without NK cells?

My take on this (which may be wrong) is that the chart is adding those that got 4 DARA to those that got 7 DARA. The chart timeline on x-axis is also not linear so it's confusing to the eye.

The IgG for the 4 DARA may have went up at the same time as the IgG from the 7 DARA went down. The chart is just confounding that IMO.

Again I may have misread it.
 
Just now noticing that the NK cell count of the responders went up to baseline levels.

Presumably that means that NK count by itself is not a useful indicator of severity, because then you’d expect relapses as soon as NK cell counts normalised.

It could still be possible that disease severity was mediated by some specific type of NK cells that didn’t get repopulated in the responders?

——

I also see that almost all of the non-responders ended up with higher NK cell counts, and most of them above the responder-threshold.

Did they try giving those more Dara, and do we have data on it?
 

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Just now noticing that the NK cell count of the responders went up to baseline levels.

Presumably that means that NK count by itself is not a useful indicator of severity, because then you’d expect relapses as soon as NK cell counts normalised.

It could still be possible that disease severity was mediated by some specific type of NK cells that didn’t get repopulated in the responders?

——

I also see that almost all of the non-responders ended up with higher NK cell counts, and most of them above the responder-threshold.

Did they try giving those more Dara, and do we have data on it?

They are not planning to retreat non-responders, but they will retreat responders if and when they relapse.


A lot of the other things have been discussed here: https://www.s4me.info/threads/long-...ory-similarities-between-cfs-and-lupus.45936/
 
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They are not planning to retreat non-responders, but they will retreat responders if and when they relapse.

I wonder why not? maybe it's so as not to dilute the evidence in favour of dara if it doesn't work but surely if they now have counts above the threshold it would give a clear indication whether there is a direct relation between NK cells and response or something more complex.

I find this decision frustrating, even if I can see why it might have been made.
 
I wonder why not? maybe it's so as not to dilute the evidence in favour of dara if it doesn't work but surely if they now have counts above the threshold it would give a clear indication whether there is a direct relation between NK cells and response or something more complex.

I find this decision frustrating, even if I can see why its been made.
Isn’t it normal in cancer research to specifically study pre-treated patients?

Like they tried X, Y and Z that are the preferred treatments, and now we’re trying T for the people that still need it?

Maybe we’ll get that down the line if Dara works.
 
Isn’t it normal in cancer research to specifically study pre-treated patients?

Like they tried X, Y and Z that are the preferred treatments, and now we’re trying T for the people that still need it?

Maybe we’ll get that down the line if Dara works.
Maybe yeah. I just think it's a shame that they're not going to retreat the non responders who now have higher NK cells because we could get some idea of whether the relationship between response and NK cells is as simple as how many you have.

It feels frustrating to potentially wait years to find out when they could start looking into it now.
 
Maybe yeah. I just think it's a shame that they're not going to retreat the non responders who now have higher NK cells because we could get some idea of whether the relationship between response and NK cells is as simple as how many you have.

It feels frustrating to potentially wait years to find out when they could start looking into it now.
It would be unblinded and they have limited funding, so that might be the reason for using the doses where it can get the most robust data.

I agree that in an ideal world, there would be some kind of way to re-treat non-responders that ended up with higher NK cells.

It would also nice to have data to see if artificially boosting NK cell count makes any difference, and if the types of NK cells matters.

I hope the Germans do some of this with their studies that have pharma funds.
 
I do really hope the responses are genuine it will/would be disappointing if the rct doesnt show any effect.
 
I do really hope the responses are genuine it will/would be disappointing if the rct doesnt show any effect.
Me too. I'm trying to be realistic and temper my hopes but this seems really promising and it's quite hard to stay level headed about it.

Even if it doesn't show an effect maybe something else will have turned up in the basic research by then.

It is exciting seeing how it might fit with all these theories and the Mensa/Armstrong/Cambridge study though.
 
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