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

[Jaybee00]

Apart from the official phase 2 trial, they are testing dara on additional patients. This is from an updated protocol where everything is unblinded.

Thanks for posting this. It would be nice to know if any of these patients were not female (i.e. males!).

The response by week 2 doesn’t jibe with the response timeline of the initial 6 patients.

 

[Jaybee00]

Link

 

[neophyte32]

Sorry, im severely ill for weeks, bedridden and sensitive, to screen. What the updates mean exactly ? Daratumumab doesn t work so well ?

 

[OrganicChilli]

Sorry, im severely ill for weeks, bedridden and sensitive, to screen. What the updates mean exactly ? Daratumumab doesn t work so well ?

It only works when you use a lot and it's likely that people will have to be retreated after some time.

 

[neophyte32]

It only works when you use a lot and it's likely that people will have to be retreated after some time.

Oohhh damned.

 

[Utsikt]

@Jonathan Edwards is there reason to believe that there’s a chance that not giving enough doses the first time around can reduce the chance of experiencing meaningful benefits from dara on the second try?

 

[Jaybee00]

s there reason to believe that there’s a chance that not giving enough doses the first time around can reduce the chance of experiencing meaningful benefits from dara on the second try?

Well we know that the NK cells are depleted quickly with the first dose. So I’m not sure what doing a couple of injections in a row does. If you space them over a longer period like every 2 months it might make sense because things start to come back.

If you do a couple of shots in a row over a short period you will reach a high concentration in your body because of the long half life of dara, etc. so the high concentration might help with killing stuff.

 

[ChronicallyOverIt]

What’s the timeline on the F&M Dara trial, it already started? Anywhere they post updates, not results, just how far along they are with dosing/how many ppl processed?

 

[Utsikt]

What’s the timeline on the F&M Dara trial, it already started? Anywhere they post updates, not results, just how far along they are with dosing/how many ppl processed?

They’ve started recruitment, and have gotten far more applications than they can accept so hopefully they’ll get enough eligible participants.

The first participants have already received their first doses.

Funding is not completely done yet, expect an update around the end of the year.

I don’t know where updates on the trial will be shared or when, but I’m sure you’ll hear about it here in no time when there is something to know.

Blinding probably means that they won’t know the results until everyone are done.