Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT07164469
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-10
First Post:
2025-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 2 Trial of CD70.CAR NK Cells for Patients With Primary Refractory or Early Relapsed Diffuse Large B-Cell Lymphoma and Hodgkin Lymphoma
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase 2 Trial of CD70.CAR NK Cells for Patients With Primary Refractory or Early Relapsed Diffuse Large B-Cell Lymphoma and Hodgkin Lymphoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
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:
This clinical research study is to learn if CD70.CAR NK cell therapy can help to control early relapsed or primary refractory DLBCL and cHL.
Detailed Description:
Primary Objective:
The primary objective of the study is to determine the efficacy of CB-derived CD70.CAR NK cell therapy in patients with primary refractory or early relapsed DLBCL and HL, as determined by the 2-year event-free survival rate.
Secondary Objectives:
* To determine the antitumor activity pf CB-derived CD70.CAR NK cells, as determined by the response rate (ORR) and complete response (CR) rate.
* To establish the safety of this treatment.
* To quantify the persistence of infused CB-derived CD70.CAR NK cells in the peripheral blood.
* To conduct comprehensive immune studies by evaluating tissue and blood-based biomarkers associated with response and resistance to CD70.CAR NK cells.
The primary objective of the study is to determine the efficacy of CB-derived CD70.CAR NK cell therapy in patients with primary refractory or early relapsed DLBCL and HL, as determined by the 2-year event-free survival rate.
Secondary Objectives:
* To determine the antitumor activity pf CB-derived CD70.CAR NK cells, as determined by the response rate (ORR) and complete response (CR) rate.
* To establish the safety of this treatment.
* To quantify the persistence of infused CB-derived CD70.CAR NK cells in the peripheral blood.
* To conduct comprehensive immune studies by evaluating tissue and blood-based biomarkers associated with response and resistance to CD70.CAR NK cells.
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-2025-06569 | OTHER | NCI-CTRP Clinical Trials Registry | View |