Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06066359
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2023-09-27
Brief Title:
Phase III Trial of Cord Blood-Derived NK Cells Genetically Engineered With NY-ESO-1 TCRIL-15 Cell Receptor for RelapsedRefractory Multiple Myeloma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase III Trial of Cord Blood-Derived NK Cells Genetically Engineered With NY-ESO-1 TCRIL-15 Cell Receptor for RelapsedRefractory Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2024-09
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 the recommended dose of NY-ESO-1 TCRIL-15 NK cells that can be given to patients with relapsed or refractory MM
To learn if the dose of NY-ESO-1 TCRIL-15 NK cells found in Part A can help to control the disease
To learn if the dose of NY-ESO-1 TCRIL-15 NK cells found in Part A can help to control the disease
Detailed Description:
Primary Objectives
Part A To assess dose-limiting toxicity DLT and determine the safety and optimal cell dose of NY-ESO-1 TCRIL-15 NK cells in patients with relapsedrefractory multiple myeloma
Part B To assess the day 90 overall response rate in patients treated at the optimal cell dose
Secondary Objectives
Assess day 180 progression-free survival PFS
Quantify the persistence of infused allogeneic donor TCR-transduced CB-derived NK cells in the recipient
To conduct comprehensive immune reconstitution studies
To obtain preliminary data on quality of life and patient experience
Assess duration of response DOR
Secondary end points
Day 180 PFS rate
NY-ESO-1 TCRIL-15 NK cell numbers in peripheral blood vs time profile
Characterization of lymphocyte populations at various time points
PROMIS-29 quality of life questionnaire score
Duration of response
Part A To assess dose-limiting toxicity DLT and determine the safety and optimal cell dose of NY-ESO-1 TCRIL-15 NK cells in patients with relapsedrefractory multiple myeloma
Part B To assess the day 90 overall response rate in patients treated at the optimal cell dose
Secondary Objectives
Assess day 180 progression-free survival PFS
Quantify the persistence of infused allogeneic donor TCR-transduced CB-derived NK cells in the recipient
To conduct comprehensive immune reconstitution studies
To obtain preliminary data on quality of life and patient experience
Assess duration of response DOR
Secondary end points
Day 180 PFS rate
NY-ESO-1 TCRIL-15 NK cell numbers in peripheral blood vs time profile
Characterization of lymphocyte populations at various time points
PROMIS-29 quality of life questionnaire score
Duration of response
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-2023-08318 | OTHER | NCI-CTRP Clinical Registry | None |