Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05397132
Other study ID # Pro00109903
Secondary ID 1R21CA267275-01
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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)
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Recruiting NCT04889937 - Usability, Adherence and Diagnostic Performance of PointCheck in Pediatric Population
Not yet recruiting NCT05820126 - Cold Versus Room Temperature Storage of Platelets for Bleeding in Hematologic Malignancy - a Pilot Trial Phase 2
Active, not recruiting NCT04509765 - A Phase II Single-arm Study of Total Body Irradiation With Linac Based VMAT and IGRT N/A
Not yet recruiting NCT06350994 - Early Assessment of Cardiac Function After Treatment With CAR-T Cells
Withdrawn NCT04282174 - CD34+ Enriched Transplants From HLA-Compatible Patients With Hematologic Malignancies Phase 2
Not yet recruiting NCT05443854 - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01) Phase 3
Withdrawn NCT03986086 - MPH966 for Prevention of Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation Phase 1/Phase 2
Completed NCT02512666 - Non Invasive Optical Imaging of WBC Count N/A
Withdrawn NCT02207764 - Reiki as a Complementary Therapy: A Pilot Study N/A
Not yet recruiting NCT02193399 - Physiotherapy in Hematopoietic Stem Cell Transplantation N/A
Terminated NCT01846429 - Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain Phase 1
Terminated NCT01215981 - Influenza Vaccine Post Allogeneic Transplant N/A
Completed NCT00333190 - CD8+ T Cell Depletion for GVHD Prophylaxis After Peripheral Blood Stem Cell Transplantation N/A
Withdrawn NCT04392128 - Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies (HYACINTHE) Phase 2
Recruiting NCT06102213 - Study To Evaluate The Safety And Efficacy of PBCLN-010 In Combination With PBCLN-014 in Participants Receiving Allogeneic Hematopoietic Cell Transplantation Phase 2
Active, not recruiting NCT04552288 - Study of Benralizumab in People With Skin Side Effects Caused by Cancer Therapies Phase 2
Completed NCT03654404 - A Proof-of-Concept Trial of a Positive Psychology Intervention for Allogeneic Stem Cell Transplant Patients N/A
Recruiting NCT05384288 - Response to Influenza Vaccination in Pediatric Oncology Patients
Recruiting NCT05084027 - Venetoclax Combining With Fludarabine and Melphalan as Conditioning Regimen for Allo-HSCT Phase 2