Table 1.
Human tDC clinical trials in the space of autoimmunity.
| Condition | Study Phase | Study Type | tDC character | Study Status | Clinicaltrials.gov Identifier | Major Reported Outcomes | Reference(s) |
|---|---|---|---|---|---|---|---|
| T1D | II | Randomized, double blind, placebo-controlled, parallel | Monocyte-derived DC generated in the presence of a mixture of antisense oligonucleotides targeting CD80, CD86, CD40 | In preparation (2023) | NCT02354911 | ||
| I/II | Randomized, double-blind, placebo controlled, parallel | Monocyte-derived autologous dendritic cell therapy (AVT001) | Enrolling | NCT03895996 | |||
| I | Non-randomized, single arm | Pro-insulin-loaded Vitamin D3-generated DC from monocytes | Completed | NTR5542 | (15) | ||
| I | Open label, pilot | Pro-insulin peptide (C19-A3)-loaded Vitamin D3-generated DC from CD14+ monocytes | Ongoing | NCT04590872 | Nakamura, R: A pilot study to evaluate the safety and feasibility of autologous tolerogenic dendritic cells loaded with proinsulin peptide (C19-A3) in patients with type 1 diabetes; https://clinicaltrials.gov/ct2/show/NCT04590872. | ||
| I | Randomized, double-blind, single arm | Monocyte-derived DC generated in the presence of a mixture of antisense oligonucleotides targeting CD80, CD86, CD40 | Completed | NCT00445913 | No adverse events identified, well-tolerated, detection of C-peptide in long-standing diabetics, increased frequency of B-cells exhibiting Breg characteristics. First ever clinical trial where tDC used in autoimmunity. | (13) | |
| MS | I/IIA | Non-randomized, parallel assignment, open label | Vitamin D3-treated DC derived from monocytes and loaded with a pool of myelin peptides | Enrolling | NCT02618902 | ||
| I/IIa | Non-randomized, parallel assignment, open label | Vitamin D3-treated DC derived from monocytes and loaded with a pool of myelin peptides | Enrolling | NCT02903537 | |||
| I | Single arm, open Label | Dexamethasone-treated DC derived from monocytes and loaded with myelin peptides or aquaporin-4- derived peptide | Completed | NCT02283671 | Treatment was safe and well-tolerated, decrease in frequency of CD8, NK, and CD14+ CD56+ cells in participants | (16) | |
| RA | I | Randomized, parallel, open label | Dexamethasone+ Vitamin D3-treated DC derived from monocytes and loaded with autologous synovial fluid | Completed | NCT01352858 | Treatment was safe and well-tolerated, Symptoms were improved in 2 patients at the highest cell dose | (17) |
| I | Interventional, single arm, open label |
DC derived from monocytes and loaded with pulsed with citrullinated filaggrin, and vimentin peptides | Completed | CRiSKCT0000035 | Treatment was safe and well-tolerated, decreased number of of IFNγ - producing T cells and autoantibody titers | ||
| I | Non-randomized, control group, open label | NF-κB inhibitor-treated DC derived from monocytes and loaded with citrullinated RA-relevant peptides | Completed | Rheumavax | Treatment was safe and well-tolerated; decrease in effector T-cells frequency and T-effector:Treg ratio; reduced pro-inflammatory cytokine and chemokine concentration in serum; decrease in DAS28 | (18) | |
| I | Single arm, open label | Dexamethasone-treated DC derived from monocytes | Completed | NCT03337165 | Treatment was safe and well-tolerated, decrease in DAS28, improvement | (19) | |
| Colitis | I | Sequential-cohorts, dose-range | Dexamethasone+ Vitamin A-treated DC derived from monocytes | Completed | 2007-003469-42 | 3 participants showed positive clinical response, 3 withdrew due to worsening of symptoms | (20) |
| Randomized, parallel, single blind | Dexamethasone-treated DC derived from monocytes | Terminated (low enrollment) | NCT02622763 | ||||
| Transplantation | I/IIa Kidney transplantation | Single-arm, open label | GM-CSF-generated DC derived from monocytes | Completed | NCT02252055 | Treatment was safe and well-tolerated | (21, 22) |
| I Kidney transplantation | Non-randomized, Sequential, dose-escalation, open-label | Vitamin D3+IL-10 treated DC derived from monocytes | Enrolling | NCT03726307 | |||
| I/II Liver transplantation | Non-randomized, prospective, open-label, non-controlled | Vitamin D3+IL-10 treated DC derived from monocytes | Active, not enrolling | NCT03164265 |
The first symbol (↓) indicates a decrease in value of experimentral intervention from control values. The second symbol (↑) indicates an increase in value of experimentral intervention from control values.