Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06383572
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-04-22
Brief Title:
Phase III Study of Engineered T Cell Receptor-Modified NK Cells Targeting PRAME in Conjunction With Lymphodepleting Chemotherapy for the Management of RelapseRefractory Myeloid Malignancies
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase III Study of Engineered T Cell Receptor-Modified NK Cells Targeting PRAME in Conjunction With Lymphodepleting Chemotherapy for the Management of RelapseRefractory Myeloid Malignancies
Status:
RECRUITING
Status Verified Date:
2024-10
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 find a recommended dose of PRAME-TCR-NK cells that can be given to patients with AML or MDS
Detailed Description:
Primary Objectives To assess dose-limiting toxicity DLT and determine the safety day 30 response rate day 180 treatment failure rate defined as disease progression or death and optimal cell dose of T cell receptor TCR modified cord blood-natural killer CB-NK cells TCR-NK targeting PRAME in patients with relapsedrefractory myeloid malignances for each of the following diseases AML MDS and Multiple Myeloma The day 30 response rate and day 180 treatment failure rate will be estimated and the estimates will be used to identify an optimal dose of PRAME-TCR-NK cells
Secondary Objectives
To assess the preliminary efficacy of PRAME-TCR-NK cells Day 30 complete and partial response rates Day 180 progression-free survival rate in patients with relapsedrefractory AML MDS and Multiple Myeloma
To quantify persistence of infused allogeneic donor PRAME-TCR CB-derived NK cells in the recipient as an integrated evaluation
To conduct comprehensive immune reconstitution studies 224 To obtain preliminary data on quality of life and patient experience PROMIS-29 quality of life questionnaire score
Secondary Objectives
To assess the preliminary efficacy of PRAME-TCR-NK cells Day 30 complete and partial response rates Day 180 progression-free survival rate in patients with relapsedrefractory AML MDS and Multiple Myeloma
To quantify persistence of infused allogeneic donor PRAME-TCR CB-derived NK cells in the recipient as an integrated evaluation
To conduct comprehensive immune reconstitution studies 224 To obtain preliminary data on quality of life and patient experience PROMIS-29 quality of life questionnaire score
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-03505 | OTHER | NCI-CTRP Clinical Registry | None |