Ignite Creation Date:
2024-05-06 @ 10:14 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03190278
Status:
RECRUITING
Last Update Posted:
2024-02-05
First Post:
2017-06-14
Brief Title:
Study Evaluating Safety and Efficacy of UCART123v12 in Patients With RelapsedRefractory Acute Myeloid Leukemia
Sponsor:
Cellectis SA
Organization:
Cellectis SA
Study Overview
Official Title:
Phase I Open Label Dose Escalation and Dose-Expansion Study to Evaluate the Safety Expansion Persistence and Clinical Activity of UCART123 Allogeneic Engineered T-cells Expressing Anti-CD123 Chimeric Antigen Receptor Administered in Patients With RelapsedRefractory Acute Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMELI-01
Brief Summary:
Phase I open-label dose-escalation and dose-expansion study evaluating the safety and efficacy of Universal Chimeric Antigen Receptor T-cell UCART targeting the Cluster of Differentiation 123 CD123 in patients with relapsedrefractory acute myeloid leukemia AML The purpose of this study is to evaluate the safety and clinical activity of Universal Chimeric Antigen Receptor T-cells targeting CD123 UCART123v12 and determine the Maximum Tolerated Dose MTD and Recommended Phase 2 Dose RP2D
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None