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

April 20, 2023 updated by: Duke University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adults

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between change in immune profile and disease relapse/resistance in CAR T therapy
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between change in molecular/genetic analysis and disease relapse/resistance in CAR T therapy
Time Frame: 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
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)
Correlation between changes in cytokine and molecular pathway profiling with disease relapse/resistance in CAR T therapy
Time Frame: 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
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2022

Primary Completion (Anticipated)

November 1, 2025

Study Completion (Anticipated)

November 1, 2025

Study Registration Dates

First Submitted

May 11, 2022

First Submitted That Met QC Criteria

May 25, 2022

First Posted (Actual)

May 31, 2022

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 20, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00109903
  • 1R21CA267275-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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