In short
Clinical trials of AUTOLOGOUS TOLEROGENIC DENDRITIC CELLS are studying this treatment in people with multiple sclerosis, especially relapsing-remitting multiple sclerosis (RRMS). The main goals are to check whether it helps control disease activity and whether it is safe when used with first-line immunotherapy.
Key points
- Clinical trial data for AUTOLOGOUS TOLEROGENIC DENDRITIC CELLS show one completed Phase 2 study in multiple sclerosis. The study focused on people with RRMS and tested the treatment together with first-line immunotherapy. Researchers mainly looked at MRI disease activity, measured by CUA lesions, and at serious safety events. The trial enrolled 45 people. Overall, the data describe an early-stage study aimed at both possible benefit and safety in a specific multiple sclerosis group.
Trial overview
The available trial data describe one interventional study of AUTOLOGOUS TOLEROGENIC DENDRITIC CELLS in multiple sclerosis. The study title says it was a dendritic cell therapy combined treatment in multiple sclerosis, and the brief summary says it tested TolDec together with first-line immunotherapy in RRMS patients.
Who was studied
The target population was people with relapsing-remitting multiple sclerosis (RRMS). RRMS is a form of multiple sclerosis where symptoms can come and go in attacks, with periods of improvement between them.
The trial record does not provide extra details about age limits, sex, or other entry rules.
What was tested
The study tested TolDec, listed as a drug intervention given intravenously, meaning through a vein. The trial also studied TolDec in combination with first-line immunotherapy, so the researchers were looking at the treatment as part of a combined approach.
The source data do not give more detail about the treatment plan beyond the intervention name and route of administration.
What researchers measured
The main efficacy outcome was the change from baseline in the number of CUA lesions at weeks 12, 18, and 24. A CUA lesion was defined in the trial as a new or persisting gadolinium-enhancing lesion on T1 MRI, or a new or enlarging lesion on T2 MRI.
In simple terms, the researchers used brain MRI scans to see whether there were fewer signs of active or new disease over time.
The safety outcomes focused on the proportion of patients with any Grade 3-4 adverse events related to product administration and related to the study product. Grade 3-4 adverse events are serious or severe medical problems recorded during the study.
Trial phase and status
This was a Phase 2 trial. Phase 2 studies are usually designed to look more closely at early signs that a treatment may help, while also continuing to monitor safety.
The study status is completed, which means the trial has finished. The enrollment was 45 participants.
What the trial data show
Based on the provided record, the main research question was whether AUTOLOGOUS TOLEROGENIC DENDRITIC CELLS, used with first-line immunotherapy, could reduce MRI signs of disease activity in RRMS. The trial also aimed to learn whether serious treatment-related side effects occurred during the study period.
Because only one completed study is listed here, the data give a focused view of early clinical research rather than a full picture of all possible uses.