Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-25 @ 1:13 PM
Study NCT ID:
NCT06066359
Status:
RECRUITING
Last Update Posted:
2025-07-29
First Post:
2023-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I/II Trial of Cord Blood-Derived NK Cells Genetically Engineered With NY-ESO-1 TCR/IL-15 Cell Receptor for Relapsed/Refractory Multiple Myeloma
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase I/II Trial of Cord Blood-Derived NK Cells Genetically Engineered With NY-ESO-1 TCR/IL-15 Cell Receptor for Relapsed/Refractory Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2025-07
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 TCR/IL-15 NK cells that can be given to patients with relapsed or refractory MM.
To learn if the dose of NY-ESO-1 TCR/IL-15 NK cells found in Part A can help to control the disease.
To learn if the dose of NY-ESO-1 TCR/IL-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 TCR/IL-15 NK cells in patients with relapsed/refractory 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 TCR/IL-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 TCR/IL-15 NK cells in patients with relapsed/refractory 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 TCR/IL-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:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2023-08318 | OTHER | NCI-CTRP Clinical Registry | View |