Ignite Creation Date:
2024-05-06 @ 9:44 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03056339
Status:
COMPLETED
Last Update Posted:
2024-03-25
First Post:
2017-02-14
Brief Title:
Umbilical Cord Blood CB Derived CAR-Engineered NK Cells for B Lymphoid Malignancies
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Dose Escalation Study Phase III of Umbilical Cord Blood-Derived CAR-Engineered NK Cells in Conjunction With Lymphodepleting Chemotherapy in Patients With RelapsedRefractory B-Lymphoid Malignancies
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
If you are reading and signing this form on behalf of a potential participant please note Any time the words you your I or me appear it is meant to apply to the potential participant
The goal of this clinical research study is to learn if giving genetically changed immune cells called CAR-NK cells after chemotherapy will improve the disease in stem cell transplant patients with relapsed has returned andor refractory has not responded to treatment B-cell lymphoma or leukemia Also researchers want to find the highest tolerable dose of CAR-NK cells to give to patients with relapsed or refractory B-cell lymphoma or leukemia The safety of this treatment will also be studied
This is an investigational study The making of and infusion of genetically changed NK cells and the drug AP1903 if you receive it explained below are not FDA approved or commercially available for use in this type of disease They are currently being used for research purposes only The chemotherapy drugs in this study fludarabine cyclophosphamide and mesna are commercially available and FDA approved
Up to 36 patients will take part in this study All will be enrolled at MD Anderson
The goal of this clinical research study is to learn if giving genetically changed immune cells called CAR-NK cells after chemotherapy will improve the disease in stem cell transplant patients with relapsed has returned andor refractory has not responded to treatment B-cell lymphoma or leukemia Also researchers want to find the highest tolerable dose of CAR-NK cells to give to patients with relapsed or refractory B-cell lymphoma or leukemia The safety of this treatment will also be studied
This is an investigational study The making of and infusion of genetically changed NK cells and the drug AP1903 if you receive it explained below are not FDA approved or commercially available for use in this type of disease They are currently being used for research purposes only The chemotherapy drugs in this study fludarabine cyclophosphamide and mesna are commercially available and FDA approved
Up to 36 patients will take part in this study All will be enrolled at MD Anderson
Detailed Description:
Objectives
Primary objective
To determine the safety and relative efficacy of Chimeric antigen receptors CARCD19-CD28-zeta-2A-iCasp9-IL15-transduced cord blood natural killer CB-NK cells in patients with relapsedrefractory CD19 B lymphoid malignancies
Secondary Objectives
1 To assess the overall response rate complete and partial response rates
2 To quantify persistence of infused allogeneic donor CAR-transduced CB-derived NK cells in the recipient
3 To conduct comprehensive immune reconstitution studies
Primary objective
To determine the safety and relative efficacy of Chimeric antigen receptors CARCD19-CD28-zeta-2A-iCasp9-IL15-transduced cord blood natural killer CB-NK cells in patients with relapsedrefractory CD19 B lymphoid malignancies
Secondary Objectives
1 To assess the overall response rate complete and partial response rates
2 To quantify persistence of infused allogeneic donor CAR-transduced CB-derived NK cells in the recipient
3 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-2018-01221 | REGISTRY | NCI CTRP-Clinical Trials Reporting Registry | None |