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The study has been early terminated due to business reasons. This decision is not related to any safety, efficacy, or regulatory concerns.
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The goal of this study is to determine if treatment with TCD601 improves beta-cell function in adults recently diagnosed with type 1 diabetes compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCD601 | Experimental | Administered one of three doses of TCD601 over a 12 week treatment period. |
|
| Placebo | Placebo Comparator | Placebo is administered over a 12 week treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCD601 | Biological | Investigational Product |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in beta-cell function as compared to placebo at week 52. | Assess any changes in beta-cell function at the end of the study (week 52) for patients treated with TCD601 (study drug) compared to subjects treated with placebo (the comparator). | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the incidence and severity of adverse | Number of adverse events compared to placebo at week 52. | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fredrik Juhlin | ITB-MED | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel | Brussels | 1090 | Belgium | |||
| UZ Leuven |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 26, 2026 | |
| Reset | Jun 22, 2026 |
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| Other |
Comparator |
|
| Leuven |
| 3000 |
| Belgium |
| Azienda Ospedaliero-Universitaria Renato Dulbecco | Catanzaro | 88100 | Italy |
| San Raffaele Hospital | Milan | 20132 | Italy |
| Luigi Sacco Hospital | Milan | 20157 | Italy |
| University of Siena | Siena | 53100 | Italy |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitari de Bellvitge | Barcelona | 08907 | Spain |
| Hospital Universitari de Girona Dr. Josep Trueta | Girona | 17007 | Spain |
| Hospital General de Segovia | Segovia | 40002 | Spain |
| Hospital Universitario Virgen del RocĂo | Seville | 41013 | Spain |
| Hospital Clinico Universitario de Valladolid | Valladolid | 47003 | Spain |
| Karolinska University Hosptial | Stockholm | Sweden |
| Dorset County Hospital NHS Foundation Trust | Dorchester | Dorset | DT1 2JY | United Kingdom |
| Liverpool University Hospitals NHS Foundation Trust | Liverpool | Merseyside | L7 8YE | United Kingdom |
| University of Birmingham | Birmingham | United Kingdom |
| Bradford Teaching Hospitals NHS Foundation Trust | Bradford | BD9 6DA | United Kingdom |
| Cambridge University Hospitals NHS Foundation Trust | Cambridge | United Kingdom |
| Ninewells Hospital | Dundee | DD1 9SY | United Kingdom |
| St George's University Hospitals NHS Foundation Trust | London | SW17 0QT | United Kingdom |
| Guy's and St. Thomas' NHS Foundation Trust | London | United Kingdom |
| East Kent Hospitals University NHS Foundation Trust | Margate | CT9 4AN | United Kingdom |
| Norfolk and Norwich University Hospitals NHS Foundation Trust | Norwich | NR4 7UY | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust | Oxford | OX3 7LE | United Kingdom |
| Northern Care Alliance NHS Foundation Trust | Salford | M6 8HD | United Kingdom |
| Swansea Bay University Health Board | Swansea | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 26, 2026 | Jun 22, 2026 | |||
| Jul 7, 2026 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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