General Information |
| Summary |
CALiPSO-1 is a Phase 1, multi-centre, dose-confirmation study to evaluate the safety and efficacy of CNTY-101 in participants with refractory B cell-mediated autoimmune diseases including those with moderate to severe systemic lupus erythematosus (SLE)/ lupus nephritis (LN), idiopathic inflammatory myopathies (IIM), and diffuse cutaneous systemic sclerosis (DcSSc). |
| Clinical trials phase |
Phase 1 |
| Start date (estimated) |
2024-08-02 |
| End date (estimated) |
2028-08-31 |
| Clinical feature |
| Label |
systemic lupus erythematosus |
| Link |
http://purl.obolibrary.org/obo/DOID_9074 |
| Description |
A lupus erythematosus that is an inflammation of connective tissue marked by skin rashes, joint pain and swelling, inflammation of the kidneys and inflammation of the tissue surrounding the heart.; Xref MGI. |
|
Administrative Information |
| NCT number |
NCT06255028 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06255028 |
| Other study identifiers |
|
| Source weblink |
https://clinicaltrials.gov/study/NCT06255028 |
| Regulatory body approval |
| Name |
Food and Drug Administration (FDA) |
| Country |
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|
| Public contact |
| Email |
calipso-1_clinicalteam@centurytx.com |
| Public email |
calipso-1_clinicalteam@centurytx.com |
| First name |
Century Therapeutics |
| Last name |
Clinical Team |
| Phone |
+1 888-506-7670 |
| Country |
|
|
| Sponsors |
Century Therapeutics, Inc.
|
Cells |
| Which differentiated cell type is used |
| Label |
natural killer cell |
| Link |
http://purl.obolibrary.org/obo/CL_0000623 |
| Description |
A lymphocyte that can spontaneously kill a variety of target cells without prior antigenic activation via germline encoded activation receptors and also regulate immune responses via cytokine release and direct contact with other cells. |
|
Recruitment |
| Recruitment Status |
Recruiting |
| Estimated number of participants |
48 |
