Mechanisms of Disease R/R in CAR-T for Hematologic Malignancies

Recruiting

• Conditions: Hematologic Malignancy

• Registration Number: NCT05397132
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2022-05-11
• Study First Submitted QC: 2022-05-25
• Study Start: 2022-05-27
• Study First Posted: 2022-05-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Ability to understand and provide signed informed consent that fulfills Institutional Review Board guidelines.
2. Has a confirmed diagnosis of hematologic malignancy and will be undergoing CAR T therapy with commercial CAR T product.
3. Patient who has a confirmed diagnosis of hematologic malignancy and will be receiving CAR T therapy under clinical trial protocol will also be eligible if the clinical trial sponsor and the investigator approve patient participation in the study.

Exclusion Criteria

• NA

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between change in immune profile and disease relapse/resistance in CAR T therapy	before CAR T therapy, 1 week after CAR T and then every 3-6 months, and at the time of disease relapse (up to 5 years)	multivariable regression

Secondary Outcome Measures

Name	Time	Method
Correlation between changes in cytokine and molecular pathway profiling with disease relapse/resistance in CAR T therapy	before CAR T therapy, 1 week after CAR T and then every 3-6 months, and at the time of disease relapse (up to 5 years)	Cytokine profiling and molecular/genetic correlation with disease relapse/resistance in CAR T therapy
Correlation between change in molecular/genetic analysis and disease relapse/resistance in CAR T therapy	before CAR T therapy, 1 week after CAR T and then every 3-6 months, and at the time of disease relapse (up to 5 years)	bulk RNA-sequencing, single cell RNA sequencing, single cell ATAC seq or metabolomics on peripheral blood samples

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States