Yann04
Senior Member (Voting Rights)
Yeah if the Documentary is anything to go by for Ritux they knew basically 20 mins after unblinding that there was no effect.
Open Norway: Plasma cell aimed treatment with daratumumab in ME/CFS (ResetME) - Haukeland University Hospital
- Thread starter Kalliope
- Start date
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- cd38 daratumumab norway resetme
Thread for the documentary: Left out (Norwegian documentary on ME)
ryanc97
Senior Member (Voting Rights)
Sad watch but they are very dedicated. LLPC depletion ftw.
What I think is more interesting is that after the RituxME trial failed P3 they still persisted in believing it was autoimmune or antibody related at least and moved on with another trial years later. Have to give them alot of credit for that. And look where we are now.
What I think is more interesting is that after the RituxME trial failed P3 they still persisted in believing it was autoimmune or antibody related at least and moved on with another trial years later. Have to give them alot of credit for that. And look where we are now.
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Utsikt
Senior Member (Voting Rights)
Update on funding from the funding thread:
3.5 MNOK (£300k, $400k) is missing as of 16th Jan 2026.
Update on recruitment (same source):
25 % started treatment
25 % waiting to start treatment
50 % not recruited yet (but applications are still being assessed).
Speculation by me:
If recruitment finishes by the summer (which seems to be the plan), the last participant will be done with their follow up 17 months later (duration mentioned in participant info), approximately at the end of 2027.
Bonus:
They have also expanded the pilot with 5 severe patients that have already been recruited.
3.5 MNOK (£300k, $400k) is missing as of 16th Jan 2026.
Update on recruitment (same source):
25 % started treatment
25 % waiting to start treatment
50 % not recruited yet (but applications are still being assessed).
Speculation by me:
If recruitment finishes by the summer (which seems to be the plan), the last participant will be done with their follow up 17 months later (duration mentioned in participant info), approximately at the end of 2027.
Bonus:
They have also expanded the pilot with 5 severe patients that have already been recruited.
V.R.T.
Senior Member (Voting Rights)
So hopefully a preprint sometime in 2028 in that case!
I am incredibly anxious to see how these patients respond. If they have a similar response to the original pilot responders it will be a sign that the effect may be real and there may be merit to the NK separation thing.
If they don't then us severe patients might need something else or something additional which wont be great news. Or it might mean dara doesn't actually work.
So I have everything crossed and will be on tenterhooks until we hear more.
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Pretty much sums up the situation. Not sure there is much else as far as possible breakthrough treatment in the next few years.
ryanc97
Senior Member (Voting Rights)
There is a bit of a worry if NK cell function is the bottleneck, people with past covid infections will have weaker NK cells (since covid damages lymphocytes) which would be a bit of a problem for Dara.
V.R.T.
Senior Member (Voting Rights)
No, unless JAK-STAT inhibitors turn out to help a subset, which I don't think is as likely as dara working, although I do think it's possible. I'm not discounting the possibility of a breakthrough in the basic science leading to treatment trials in the near future but as far as treatments already being studied that might do something significant its pretty much dara (and isa) or JAK-STAT imo.
V.R.T.
Senior Member (Voting Rights)
That is a worry! Although maybe there are drugs that can increase NK function in pwME if its related to drug action. Or there are other anti cd38s or LLPC depleting drugs (depending on whether its llpc or other immune cells we want to target) that we can give low NK cell people.
Edit: Oh weaker not fewer. That is a concern. Bloody covid.
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Kitty
Senior Member (Voting Rights)
Would it make a great deal of difference to the underlying ME/CFS? Deterioration could affect people's severity level, meaning that when it comes to participation they have greater access needs than before, but severely ill people who haven't deteriorated due to Covid would be in the same situation.
I don't think it's very clear about the difference mild Covid makes to NK cells, or what proportion of people any changes affect—it seems unlikely anyone would spend a lot of money testing large groups of recovered people to find out. There might be data on immune cell count and function from those who've been hospitalised with severe Covid, but that probably couldn't be extrapolated to people who've had mild illness.
Kalliope
Senior Member (Voting Rights)
I was thinking more in general how repeated covid-infections will make clinical trials more complex as patients may risk getting a deterioration of their illness and/or new additional illnesses while testing whether or not a treatment improves their situation.
Kitty
Senior Member (Voting Rights)
Yeah, I guess it depends how different it is from normal. There have always been things coming along and adding complications; some people with ME/CFS are also affected by getting a bad dose of 'flu or developing new onset migraine, for instance, and others might pick up additional diagnoses. We'd have to be clear in what ways Covid is different, especially as it's always hard to be certain about the cause of any changes.
Utsikt
Senior Member (Voting Rights)
That’s why you need trials with large enough groups. Those kind of events would be randomly distributed and shouldn’t affect the final result on average.