Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-31 @ 12:52 AM
Study NCT ID:
NCT05397132
Status:
RECRUITING
Last Update Posted:
2025-09-02
First Post:
2022-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanisms of Disease R/R in CAR-T for Hematologic Malignancies
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
Mechanisms of Disease Relapse/Resistance in CAR T Therapy for Hematologic Malignancies
Status:
RECRUITING
Status Verified Date:
2025-05
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:
The primary purpose of this IRB protocol is to perform immune profiling focusing on the measurement of Myeloid derived suppressor cells (MDSCs) over time in patients receiving Chimeric antigen receptor (CAR) T therapy and determine the correlation between immune profile and disease relapse/resistance in CAR T therapy.
Detailed Description:
The primary purpose of this IRB protocol is to perform immune profiling focusing on the measurement of MDSCs over time in patients receiving CAR T therapy and determine the correlation between immune profile and disease relapse/resistance in CAR T therapy. Blood samples and accompanying health information (including PHI) may be collected from standard of care, non-significant risk, research-only procedures or obtained from our Division Research Repository and Database (Duke IRB Pro00006268) or DUHS Biospecimen Research and Biobanking protocol (Duke IRB Pro00035974). All hematologic malignancy patients treated with commercial CAR T products will be screened and enrolled for the study.
The investigators will perform multivariable regression to see if the number and function of MDSCs can be used as independent factors to predict disease relapse at 1 year after CAR T treatment, overall survival or progression-free survival. The studies will not require additional invasive procedure solely for the study.
The investigators will use blood samples that are performed as part of standard care. Therefore, no additional procedure is needed. The major potential risk associated with the study is the breach of confidentiality.
The investigators will perform multivariable regression to see if the number and function of MDSCs can be used as independent factors to predict disease relapse at 1 year after CAR T treatment, overall survival or progression-free survival. The studies will not require additional invasive procedure solely for the study.
The investigators will use blood samples that are performed as part of standard care. Therefore, no additional procedure is needed. The major potential risk associated with the study is the breach of confidentiality.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|---|
| 1R21CA267275-01 | NIH | None | https://reporter.nih.gov/quic… | View |