Table 1.
Examples of clinical trials for antigen-specific immunotherapy of T1D (current and completed within the past five years).
| Intervention | Components of ASITs | Endotype-related inclusion criteria | Status | Trial size | Sponsor | NCT number | Stage |
|---|---|---|---|---|---|---|---|
| IMCY-T1D-001 | Small synthetic peptide (ImotopesTM) | HLADR3-positive and/or HLADR4-positive | Completed in 2019 | 41 | Imcyse SA | NCT03272269 | Phase 1 |
| IMCY-T1D-002 | Small synthetic peptide (ImotopesTM) | HLADR3-positive and/or HLADR4-positive | Completed in 2019 | 30 | Imcyse SA | NCT04190693 | Phase 1 |
| IMCY-T1D-003 | Small synthetic peptide (ImotopesTM) | HLADR3-positive and/or HLADR4-positive | Recruiting | 108 | Imcyse SA | NCT04524949 | Phase 2 |
| Tolerogenic Dendritic Cell Vaccine PIpepTolDCs |
Proinsulin Peptide (C19-A3) | Positive for DRB1 × 04:01, *04:02 and/or *04:04 allele but without the protective HLA-DRB1 × 15:01-DQA1 × 01:02-DQB1 × 06:02 haplotype | Recruiting | 7 | City of Hope Medical Center | NCT04590872 | Phase 1 |
| C19-A3 GNP | C19-A3 proinsulin peptide coupled to gold | Positive for DRB1 × 0401 allele | Unknown | 8 | Cardiff University | NCT02837094 | Phase 1 |
| GAD-Alum | rhGAD65-alum (Diamyd®), Etanercept and Vitamin D | Positive for GAD65 antibodies | Completed in 2019 | 20 | Johnny Ludvigsson (Linköping University) | NCT02464033 | Phase 2 |
| GABA-GAD | GAD and GABA | Positive for GAD65 antibodies | Completed In 2022 | 101 | University of Alabama at Birmingham | NCT02002130 | Phase 1 |
| GAD-alum (Diamyd®) | rhGAD65 adsorbed to Alhydrogel | HLA DR3-DQ2 haplotype | Recruiting | 6 | Linköping University | NCT05351879 | Phase 1 Phase 2 |
| GAD-alum (Diamyd®) | rhGAD65, formulated in aluminum hydrogel | High GAD antibody titers (>190 U/ml) | Completed in 2022 | 14 | Norwegian University of Science and Technology | NCT04262479 | Phase 2 |
| GAD-Alum (Diamyd®) | GAD-Alum (Diamyd) combined with Vitamin D and Ibuprofen | Elevated GAD65 antibodies | Completed in 2017 | 60 | Johnny Ludvigsson (Linköping University) | NCT01785108 | Phase 2 |
| GAD-Alum (DIAGNODE-1) | Intra-lymph node rhGAD65 Alum + Vitamin D | Positive for GAD Antibodies | Completed in 2019 | 12 | Johnny Ludvigsson (Linköping University) | NCT02352974 | Phase 1 |
| GAD-Alum DIAGNODE-2 | Intra-lymph node Alhydrogel®-formulated rhGAD65 | Positive for GAD65 Antibodies | Completed in 2021 | 109 | Diamyd Medical AB | NCT03345004 | Phase 2 |
| DIAGNODE-3 | Intra-lymph node rhGAD65 formulated in Alhydrogel® | HLA DR3-DQ2 haplotype and positive for GAD65 antibodies | Recruiting | 330 | Diamyd Medical AB | NCT05018585 | Phase 3 |
| DIAPREV-IT2 | Alum-GAD (Diamyd®) and Vitamin D3 | Positive for GAD65 Antibodies plus at least one other | Terminated In 2019 | 26 | Lund University | NCT02387164 | Phase 2 |
| MultiPepT1De | Multiple Islet Peptides | HLA-DR4 (DRB1 × 0401) genotype | Completed in 2018 | 27 | King’s College London | NCT02620332 | Phase 1 |
| TOL-3021 | Plasmid for the hINS gene | At least one of GAD65, IA-2, ZnT8, or insulin antibodies | Active, not recruiting | 78 | Tolerion, Inc. | NCT03895437 | Phase 2 |
| TOPPLE T1D | PPI, TGF-β1, IL-10 and IL-2 | At least one diabetes-related autoantibody present | Recruiting | 48 | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NCT04279613 | Phase 1 |
rhGAD65 (recombinant human glutamic acid decarboxylase), GAD (glutamic acid decarboxylase), GABA (gamma-amino butyric acid), alum (aluminum hydroxide), HLA (human leukocyte antigens), PPI (preproinsulin), TGF-β1 (transforming growth factor beta 1) and IL (Interleukin).