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Trial Report Plasma cell targeting with the anti-CD38 antibody daratumumab in ME/CFS -a clinical pilot study, 2025, Fluge et al
Jonathan Edwards
Senior Member (Voting Rights)
Antibodies to peptides are pretty meaningless. They seem to have found antibodies that bind to peptides from a range of proteins that share some sequence similarity to microbial proteins, which is almost certainly completely irrelevant. Peptides with similar sequences exist everywhere in everything. If they had found a qualitative difference in antibodies to one protein I would have been interested. This sort of result has been produced for all sorts of diseases for decades and tells us nothing as far as I can see.
Here is the revised PILOT protocol.
“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.
I think this jibes with a comment @Jonathan Edwards made earlier somewhere on this forum that one initial dose would be sufficient to deplete long-lived plasma cells.
“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.
I think this jibes with a comment @Jonathan Edwards made earlier somewhere on this forum that one initial dose would be sufficient to deplete long-lived plasma cells.
I’m assuming that they didn’t go with this revised protocol for the full Phase 2 study because they didn’t want to take the risk that weren’t fully depleting LLPC’s.
With this very small sub-sample they could take the risk of doing fewer injections.
FWIW, this is very different from the multiple myeloma dosing, which I believes entails 8 initial injections.
With this very small sub-sample they could take the risk of doing fewer injections.
FWIW, this is very different from the multiple myeloma dosing, which I believes entails 8 initial injections.