Tolerogenic Dendritic Cell Therapy for Rheumatoid Arthritis (TOLERANT)
Rheumatoid Arthritis
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Tolerogenic Dendritic Cells
Eligibility 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
Sites / Locations
- Radboud University Medical Centre
- University Medical Centre UtrechtRecruiting
- Utrecht University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Intranodal TolDCB29 (low dose)
Intranodal TolDCB29 (intermediate dose)
Intranodal TolDCB29 (high dose)
Intranodal TolDCB29 (recommended dose)
Two administrations of 5 million autologous mature tolerogenic monocyte-derived Dendritic Cells loaded with the B29 peptide of HSP70 (TolDCB29). This cohort will consist of three patients.
Two administrations of 10 million autologous mature tolerogenic monocyte-derived Dendritic Cells loaded with the B29 peptide of HSP70 (TolDCB29). This cohort will consist of three patients.
Two administrations of 15 million autologous mature tolerogenic monocyte-derived Dendritic Cells loaded with the B29 peptide of HSP70 (TolDCB29). This cohort will consist of three patients.
Two administrations of the recommended dose of autologous mature tolerogenic monocyte-derived Dendritic Cells loaded with the B29 peptide of HSP70 (TolDCB29). The recommended dose will be advised by the data safety monitoring board after data review of the first three arms. This cohort will consist of nine patients.