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

NCT05397132 | Recruiting

• 2 other identifiers: Pro001099031R21CA267275-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Malignancy

Keywords

CAR-T

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

• 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)

Interventions

Blood draw GENETIC

Patients will provide a blood draw for research and repository

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults

You may qualify if:

• Ability to understand and provide signed informed consent that fulfills Institutional Review Board guidelines.
• Has a confirmed diagnosis of hematologic malignancy and will be undergoing CAR T therapy with commercial CAR T product.
• 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.

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood for banking

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Yubin Kang

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Quinna Lawson

CONTACT

919-681-3095; quinna.marshburn@duke.edu

Peggy Alton

CONTACT

919-684-9220; peggy.alton@duke.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 31, 2022
• Study Start: May 27, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)