General Information |
| Summary |
This is a phase 1, first-in-human (FIH), open-label, multicohort study to evaluate the safety, tolerability and preliminary efficacy of CLL1 or CD33 target Chimeric antigen receptor (CAR) -induced pluripotent stem cells derived NK cells in patients with relapsed/refractory AML. |
| Description |
Acute myelogenous leukemia (AML) is a potentially cur-able disease; 70% of newly diagnosed patients achievecomplete remission with first-line therapy, but prognosisworsens for relapsed disease in both pediatric and adultpatients.C-type lectin-like molecule-1 and cluster of differentiation antigen 33 has attracted the researchers' attention due to its high expression in AML while being absent in normal hematopoietic stem cell. Accumulating evidence have demonstrated CLL-1 or CD33 is an ideal target for AML. |
| Clinical trials phase |
Phase 1 |
| Start date (estimated) |
2024-04-30 |
| End date (estimated) |
2026-08-31 |
| Clinical feature |
| Label |
acute myeloid leukemia |
| Link |
http://purl.obolibrary.org/obo/DOID_9119 |
| Description |
A myeloid leukemia that is characterized by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal blood cells.; OMIM mapping confirmed by DO. [SN]. |
|
Administrative Information |
| NCT number |
NCT06367673 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06367673 |
| Other study identifiers |
|
| Source weblink |
https://clinicaltrials.gov/study/NCT06367673 |
| Public contact |
| Email |
hehuangyu@126.com |
| Public email |
hehuangyu@126.com |
| First name |
He |
| Last name |
Huang |
| Phone |
+ 86-13605714822 |
| City |
Zhejiang |
| Country |
|
|
| Sponsors |
Zhejiang University
|
| Collaborators |
|
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 |
24 |
