Mechanisms of Disease R/R in CAR-T for Hematologic Malignancies
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Ability to understand and provide signed informed consent that fulfills Institutional Review Board guidelines.
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Has a confirmed diagnosis of hematologic malignancy and will be undergoing CAR T therapy with commercial CAR T product.
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke University | Durham | North Carolina | United States | 27710 |
Sponsors and Collaborators
- Duke University
- National Institutes of Health (NIH)
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Yubin Kang, Duke University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00109903
- 1R21CA267275-01