Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06641648
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
A Phase I Single-arm Clinical Study of Donor NK Cells Infusion Combined with Low-dose Interleukin-2 in the Treatment of Acute Myeloid Leukemia Relapse After Allogeneic Hematopoietic Stem Cell Transplantation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Single-arm Clinical Study of Donor NK Cells Infusion Combined with Low-dose Interleukin-2 in the Treatment of Acute Myeloid Leukemia Relapse After Allogeneic Hematopoietic Stem Cell Transplantation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-centre single-arm open-label early clinical study to evaluate the safety tolerability and preliminary efficacy of donor NK cells injection combined with low-dose interleukin-2 in the treatment of acute myeloid leukemia AML relapse after allogeneic hematopoietic stem cell transplantation allo-HSCT
Detailed Description:
This is a dose-escalation study of non-genetically modified natural killer cells derived from a healthy donor The relapsed AML patients after allo-HSCT will receive donor NK cells injection s followed by low-dose interleukin-2 No graft-versus-host disease GVHD prevention will be conducted before or after infusion Dose-limiting toxicity incidence of adverse events disease response and PKPD will be detected post-infusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None