ryanc97
Senior Member (Voting Rights)
So the problem with self trials and logistics is not everyone has the luxury of buying enough doses, and also testing. Some did 2 doses, some did 4. By some I mean like 1 or 2 people
Trial Report Plasma cell targeting with the anti-CD38 antibody daratumumab in ME/CFS -a clinical pilot study, 2025, Fluge et al
ryanc97
Senior Member (Voting Rights)
@Rick Sanchez I think to your post, the number of people who try Dara is much less than you think it is. Why?
1. You must know of the study. Most ME people have no idea about it.
2. You must believe in the study. People who heard of it but don't bother realizing how important it is.
3. You must want/willing to try the drug.
4. You must know how to get the drug.
5. You must buy the drug and bring it from wherever you got it to your home.
5. You must administer the drug
When you filter, the amount of people is pretty much a handful. You would be able to use your fingers to count.
Even if you are at stage 3, you want to try it, you may not know how to get it, or not able to get it. Or you might know how to get it but cant because you are bedbound, etc.
So there are really not alot of people. You can use your fingers to count, like I said.
1. You must know of the study. Most ME people have no idea about it.
2. You must believe in the study. People who heard of it but don't bother realizing how important it is.
3. You must want/willing to try the drug.
4. You must know how to get the drug.
5. You must buy the drug and bring it from wherever you got it to your home.
5. You must administer the drug
When you filter, the amount of people is pretty much a handful. You would be able to use your fingers to count.
Even if you are at stage 3, you want to try it, you may not know how to get it, or not able to get it. Or you might know how to get it but cant because you are bedbound, etc.
So there are really not alot of people. You can use your fingers to count, like I said.
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Right, because the Kolibri clinic in Sandnes (Stavanger) Norway was administering rituximab to patients outside of clinical trials, so a lot of people took the drug here without any success. This is not the case with Dara.
ryanc97
Senior Member (Voting Rights)
I even heard of an anecdote of a Dara partial responder who has alot more energy in the early mornings!
But I will say this: there are partial responses on Dara. It’s too early to tell still.
And the amount of people who have tried and waited a long while is really small.
However for Teclistamab, it is definitely a no. I have seen enough evidence that it does nothing, even in full doses, and often results in worsening
But I will say this: there are partial responses on Dara. It’s too early to tell still.
And the amount of people who have tried and waited a long while is really small.
However for Teclistamab, it is definitely a no. I have seen enough evidence that it does nothing, even in full doses, and often results in worsening
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V.R.T.
Senior Member (Voting Rights)
So if your information is accurate, we have 6 weeks uniform start of response in p1, but in the LC patients with less doses and the retreated patient response at week 2, and then 12-16 weeks in these people trying it that you've been in contact with...
That's a lot less neat that the uniform 6 week response start from the pilot.
Agreed, I was definitely hoping for a 'hey quite a few people have tried it outside the trial and are getting better' type situation.
But as other people have pointed out there are other factors that might be at play here.
2 weeks til Charite presentation seems like an eternity right now, let alone 2 years. But yeah I don't encorage anyone to try it before p2 at this point.
V.R.T.
Senior Member (Voting Rights)
Are you saying only one or two people have done 4+ doses?
I think the full dosing schedule is 5 for p2 isnt it?
ryanc97
Senior Member (Voting Rights)
Yes but you have to remember people are not taking the protocol, due to logistics or whatever. Some have done two doses 2 months apart etc because they don’t have enough Dara etc.
Some have even taken Dara without NK cells with no response. But because that person didn’t take NK cells, which is a stupid thing to do, we will never know why.
ryanc97
Senior Member (Voting Rights)
Well, I would say closer to 2 or 3 have done 4 or more doses. It’s a tiny number.
Admittedly there are no perfect responders like in FM, but I think partial response is encouraging.
Especially given there were a few cases of low NK like 130 and 180 doing Dara.
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ryanc97
Senior Member (Voting Rights)
I will say from the data I have, I believe having high baseline NK cells is not enough.
You need higher cd38- NK cells, aka the NK cells left after Dara no1, the ones that survive fratricide.
At least that seems to be the pattern in my dataset. But it’s smaller than FM study and not everyone does the same schedule and dose etc.
Worse case scenario it could be only women that respond. But the partial responders are all male so far, so that’s not true. I still believe the clue is in NK cells
You need higher cd38- NK cells, aka the NK cells left after Dara no1, the ones that survive fratricide.
At least that seems to be the pattern in my dataset. But it’s smaller than FM study and not everyone does the same schedule and dose etc.
Worse case scenario it could be only women that respond. But the partial responders are all male so far, so that’s not true. I still believe the clue is in NK cells
V.R.T.
Senior Member (Voting Rights)
Can you say what the degree of these partial responses are in terms of step count, functioning etc?
Do you have any links about these CD38- NK Cells? I would like to learn more.
Anyway this is quite interesting. Can I ask how you contacted/discovered these people?
ryanc97
Senior Member (Voting Rights)
Well it’s more like anecdotes like “less PEM”, can go back to work part time, can wake up early and feeling refreshed etc.
Not really quantitative measures because we are dealing with people not in a clinical trial.
There is one worsening case sadly, but I am not sure if it’s permanent or just nasty side effects. Well have to wait and see.
It’s more like you ask someone how they are doing and they tell you.
The most quantitative is Abraham on X, the 5 months guy, who went from maybe 500 to 3k steps? He has posted his step count on X
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ryanc97
Senior Member (Voting Rights)
I think the effect in phase 2 will not be so clear cut as phase 1. We will probably see the same pattern (NK cells and response), but the correlation will not be as strong as 0.77 like in the study. There will be people with “good” NK cells that don’t respond.
Maybe like 40% or 30% response rate.
There is probably some other factor involved. Maybe it’s the cd38- NK cells. Then FM will have to investigate that.
Maybe like 40% or 30% response rate.
There is probably some other factor involved. Maybe it’s the cd38- NK cells. Then FM will have to investigate that.
V.R.T.
Senior Member (Voting Rights)
That's an interesting prediction. 30 or 40% response rate would be quite low, lower even than the distribution of responders and non responders in the pilot where NK cells weren't an entry requirement...
ryanc97
Senior Member (Voting Rights)
Yes, as above my current hypothesis is it’s about cd38- NK cells.
In MM these are shown to have superior ADCC capacity and MM researchers engineer CD38 low or KO expanded NK cell lines and do experiments with them.
But the main idea is I believe you need some kind of “correct setup” of your immune system for Dara to work. And I guess we need to figure out what this setup is. And it’s correlation to NK cells
I still don’t think it’s subtypes. FM just need to figure out why it worked in some and not others.
I also don’t think the p1 is down to placebo or luck.
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V.R.T.
Senior Member (Voting Rights)
Do they do this in human subjects?
V.R.T.
Senior Member (Voting Rights)
I'm still not clear why you predict such a low response rate in the p2 trial.
Surely we would expect to see at least a similar distribution of responses as the pilot if NK cells are part of it, even if not everyone with higher NK cells has enough CD38- NK cells to respond.
ryanc97
Senior Member (Voting Rights)
Just from the experience asking people who did Dara. It’s abit lower than the study and no full remission yet. Maybe it’s just time