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

Last updated: May 15, 2024
Sponsor: Duke University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hematologic Neoplasms

Blood Cancer

Neoplasms

Treatment

Blood draw

Clinical Study ID

NCT05397132
Pro00109903
1R21CA267275-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Ability to understand and provide signed informed consent that fulfillsInstitutional Review Board guidelines.

  2. Has a confirmed diagnosis of hematologic malignancy and will be undergoing CAR Ttherapy with commercial CAR T product.

  3. Patient who has a confirmed diagnosis of hematologic malignancy and will bereceiving CAR T therapy under clinical trial protocol will also be eligible if theclinical trial sponsor and the investigator approve patient participation in thestudy.

Exclusion

Exclusion Criteria:

  • NA

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Blood draw
Phase:
Study Start date:
May 27, 2022
Estimated Completion Date:
November 01, 2025

Study 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.

Connect with a study center

  • Duke University

    Durham, North Carolina 27710
    United States

    Active - Recruiting

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