Tolerogenic Dendritic Cell Therapy for Rheumatoid Arthritis
Tolerogenic Dendritic Cell Therapy for Rheumatoid Arthritis: the TOLERANT Trial
This study is testing a new treatment using special immune cells to see if it can help people with rheumatoid arthritis stay in remission and feel better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UMC Utrecht Academic / other |
| Drugs / interventions | prednisone |
| Locations | 3 sites (Nijmegen and 2 other locations) |
| Trial ID | NCT05251870 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and feasibility of using tolerogenic dendritic cells (TolDCB29) to induce immune tolerance in patients with rheumatoid arthritis. The approach involves administering autologous mature dendritic cells loaded with a specific peptide to patients who are in remission or have low disease activity while on stable medication. The study aims to assess the immune response to this treatment and its effect on disease activity. It is designed as a Phase I/II, open-label, dose-escalation trial.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with rheumatoid arthritis in remission or low disease activity on stable doses of disease-modifying anti-rheumatic drugs.
Not a fit: Patients with active infections, those using JAK inhibitors, or those who have had recent glucocorticoid injections may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a novel way to achieve long-term remission in rheumatoid arthritis by inducing immune tolerance.
How similar studies have performed: While the use of dendritic cell therapy is an emerging field, this specific approach has not been widely tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of rheumatoid arthritis (RA) according to the criteria which were valid at time of diagnosis (i.e. 1987 Rheumatoid Arthritis Classification or 2010 American College of Rheumatology/EULAR RA Classification Criteria) * Stable dose, for at least 12 weeks, of any combination of disease-modifying antirheumatic drugs and glucocorticoids (maximum of 7.5 mg per day), with exception of those drugs that are part of the exclusion criteria. * Disease in remission or in low disease activity for at least 12 weeks (disease activity score of 28 joints \< 3.2) * Able and willing to give informed consent and to comply with the study protocol Exclusion Criteria: * Intramuscular or intra-articular glucocorticoid injection during 12 weeks prior to inclusion * Use of JAK inhibitors * Active or chronic infection (except fungal nail infection) * Infection requiring hospitalization or IV antibiotics within 6 weeks of baseline * Immunization with live vaccine within 6 weeks of baseline * History of malignancy (except treated basal cell carcinoma of skin) * Use of other investigational medicinal products within 30 days prior to study entry * Major surgery within 8 weeks of baseline or planned within 12 weeks from baseline * Pregnancy, or women planning to become pregnant within the study period, or women who are breast feeding * Hb\<6 mmol/L; neutrophils\< 2.00 x10\^9/L; platelets \<150x10\^9/L; alanine aminotransferase or alkaline phosphatase\>2x upper limit of normal; renal insufficiency (clearance \< 60 ml/min) at screening visit * Poor venous access or medical condition precluding leukapheresis * Serious or unstable co-morbidity deemed unsuitable by PI, e.g. chronic obstructive pulmonary disease, cardiac failure * Individuals of child bearing potential unwilling to use adequate contraception for duration the of study
Where this trial is running
Nijmegen and 2 other locations
- Radboud University Medical Centre — Nijmegen, Netherlands (Active_not_recruiting)
- University Medical Centre Utrecht — Utrecht, Netherlands (Recruiting)
- Utrecht University — Utrecht, Netherlands (Active_not_recruiting)
Study contacts
- Principal investigator: Jacob M van Laar, MD, PhD — UMC Utrecht
- Study coordinator: Arie J Stoppelenburg, PhD
- Email: a.j.stoppelenburg@umcutrecht.nl
- Phone: +31302535589
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.