Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT06234904
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-31
First Post:
2024-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of IBR733 Cell Injection in Acute Myeloid Leukemia
Sponsor:
Imbioray (Hangzhou) Biomedicine Co., Ltd.
Organization:
Study Overview
Official Title:
An Open-label, Multi-center, Phase I Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of IBR733 Cell Injection in Acute Myeloid Leukemia
Status:
NOT_YET_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:
None
Brief Summary:
This is an open-label clinical study: phase Ia is the dose-escalation part, and phase Ib is the dose-expansion part. The phase Ia study is to evaluate the safety, tolerability, recommended phase II dose, pharmacokinetics, immunogenicity and preliminary efficacy of IBR733 cell injection in relapsed/refractory acute myeloid leukemia (AML).
Detailed Description:
Phase Ia is the dose escalation part which adopts the "3+3" dose escalation design protocol. The dose is respectively 5.0×10\^9 cells, 7.5×10\^9 cells and 10.0×10\^9 cells. 3-6 subjects will be enrolled at every dose level. Subjects who have signed the Informed Consent Form (ICF) will be reviewed for inclusion/exclusion criteria (this process is called "screening"), and eligible subjects will be treated with IBR733 cell injection after lymphodepletion therapy. The administration of IBR733 cell injection is performed on day 1 and day 8 of each cycle (21 days). The first and second subjects in the same group shall be enrolled at an interval of at least 21 days, for the purpose of ensuring their safety.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: