Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522373
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Phase I Trial of MT-0169 in CD38 Acute Leukemia With RelapsedRefractory or Measurable Residual Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase I Trial of MT-0169 in CD38 Acute Leukemia With RelapsedRefractory or Measurable Residual Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
To learn if MT-0169 is safe to give to patients with AML or T-ALL The effects of this drug will also be studied
Detailed Description:
Primary Objective
To study the safety and tolerability of MT-0169
Secondary Objectives
To study preliminary efficacy of MT-0169 in terms of morphologic and MRD response rates and survival outcomes
Exploratory Objectives
To determine the plasma concentration and pharmacokinetic PK parameters of MT-0169
To estimate proportion of MRD patients who achieved 1 log fold reduction in MRD burden
To explore additional response and survival outcomes potential biomarkers of response resistance and impact on immune microenvironment
To study the safety and tolerability of MT-0169
Secondary Objectives
To study preliminary efficacy of MT-0169 in terms of morphologic and MRD response rates and survival outcomes
Exploratory Objectives
To determine the plasma concentration and pharmacokinetic PK parameters of MT-0169
To estimate proportion of MRD patients who achieved 1 log fold reduction in MRD burden
To explore additional response and survival outcomes potential biomarkers of response resistance and impact on immune microenvironment
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