Ignite Creation Date:
2024-05-06 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05092451
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2021-10-13
Brief Title:
Phase III Study of CAR70- Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of RelapseRefractory Hematological Malignances
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase III Study of CAR70- Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of RelapseRefractory Hematological Malignances
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:
The goal of this clinical research study is to learn about the safety of giving immune cells called natural killer NK cells with chemotherapy to patients with leukemia lymphoma or multiple myeloma
Immune system cells such as NK cells are made by the body to attack foreign or cancerous cells Researchers think that NK cells you receive from a donor may react against cancer cells in your body which may help to control the disease
Immune system cells such as NK cells are made by the body to attack foreign or cancerous cells Researchers think that NK cells you receive from a donor may react against cancer cells in your body which may help to control the disease
Detailed Description:
Primary Objective
To determine the safety efficacy and optimal cell dose of CAR70IL15-transduced CB-NK cells in patients with relapsedrefractory hematological malignances The efficacy and optimal dose will be identified for individual diseases
Secondary Objectives
To quantify persistence of infused allogeneic donor CAR-transduced CB-derived NK cells in the recipient
To conduct comprehensive immune reconstitution studies
To determine the safety efficacy and optimal cell dose of CAR70IL15-transduced CB-NK cells in patients with relapsedrefractory hematological malignances The efficacy and optimal dose will be identified for individual diseases
Secondary Objectives
To quantify persistence of infused allogeneic donor CAR-transduced CB-derived NK cells in the recipient
To conduct comprehensive immune reconstitution studies
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-2021-12093 | OTHER | NCI-CTRP Clinical Trials Reporting | None |