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

Hematologic Malignancy Clinical Trial

Official title:

Mechanisms of Disease Relapse/Resistance in CAR T Therapy for Hematologic Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05397132
• Other study ID #: Pro00109903
• Secondary ID: 1R21CA267275-01
• Status: Recruiting
• Start date: May 27, 2022
• Est. completion date: November 1, 2025

Study information

• Verified date: May 2024
• Source: Duke University
• Contact: Quinna Lawson
• Phone: 919-681-3095
• Email: quinna.marshburn[@]duke.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms
• Neoplasms

Intervention

Genetic:
• Blood draw
Patients will provide a blood draw for research and repository

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between change in immune profile and disease relapse/resistance in CAR T therapy	multivariable regression	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)
Secondary	Correlation between change in molecular/genetic analysis and disease relapse/resistance in CAR T therapy	bulk RNA-sequencing, single cell RNA sequencing, single cell ATAC seq or metabolomics on peripheral blood samples	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)
Secondary	Correlation between changes in cytokine and molecular pathway profiling with disease relapse/resistance in CAR T therapy	Cytokine profiling and molecular/genetic correlation 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)