Tolerogenic Dendritic Cell Therapy for Rheumatoid Arthritis
Status:
Recruiting
Trial end date:
2025-08-01
Target enrollment:
Participant gender:
Summary
Rationale: In rheumatoid arthritis, immune cells cause joint inflammation and destruction in
response to autoantigens. Immunosuppressive therapies offer relief but fail to induce
tolerance to autoantigens. Injection of antigen-loaded tolerogenic dendritic cells induces
immune tolerance and ameliorates disease in arthritis models. The investigators hypothesize
that dendritic cell therapy with TolDCB29 is safe and induces immune tolerance in rheumatoid
arthritis patients.
Objective: The aim of the study is to demonstrate the safety and feasibility of intranodal
TolDCB29 administration. Secondary objectives are the characterization of B29-peptide
specific immune reactivity in response to TolDCB29 treatment and the evaluation of the effect
of the treatment on disease activity.
Study design: Phase I/II, open-label, dose-escalation clinical trial. Study population: Adult
patients (>18 years) with rheumatoid arthritis in remission or low disease activity while on
disease modifying anti-rheumatic drugs (DMARD) will be included. Any combination and dose of
DMARD is allowed, with exception of Janus kinase inhibitors. Concomitant use of a low dose of
prednisone (7.5 mg per day or below) is allowed. Medication should be stable for at least
twelve weeks. 18 patients will undergo the experimental treatment.
Intervention: Study participants will receive two intranodal injections with the TolDCB29
product with a four-week interval. During the first phase of the study dose escalation is
performed, in which the first group (n=3) receives two "low dose" injections, the second
group (n=3) receives two "intermediate dose" injections, and the third group (n=3) receives
two "high dose" injections. During the second phase, a fourth group (n=9) will receive the
highest dosage without attributable serious adverse events thus far.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
UMC Utrecht
Collaborators:
Dutch Arthritis Association Health Holland Radboud University Medical Center Trajectum Pharma B.V. Utrecht University ZonMw: The Netherlands Organisation for Health Research and Development