Understanding immune responses in patients receiving CAR-T therapy for blood cancers
Mechanisms of Disease Relapse/Resistance in CAR T Therapy for Hematologic Malignancies
This study looks at how the immune system changes in blood cancer patients receiving CAR-T therapy to see if certain immune cells can help predict their chances of recovery or relapse.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | CAR T, Chimeric antigen receptor |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT05397132 on ClinicalTrials.gov |
What this trial studies
This observational study aims to profile the immune system of patients with hematologic malignancies who are undergoing CAR T therapy, specifically focusing on the measurement of Myeloid derived suppressor cells (MDSCs) over time. Researchers will analyze blood samples collected as part of standard care to determine how these immune profiles correlate with disease relapse and resistance to treatment. The study will utilize multivariable regression analysis to assess whether MDSC levels can predict outcomes such as overall survival and progression-free survival one year after treatment. Importantly, no additional invasive procedures are required for participation.
Who should consider this trial
Good fit: Ideal candidates are patients with a confirmed diagnosis of hematologic malignancy who are scheduled to receive CAR T therapy.
Not a fit: Patients who are not undergoing CAR T therapy or do not have a hematologic malignancy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of immune responses in CAR T therapy, potentially guiding better treatment strategies for patients with hematologic malignancies.
How similar studies have performed: While the specific focus on MDSCs in relation to CAR T therapy is novel, similar studies have shown promise in understanding immune responses in cancer treatments.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Durham, North Carolina
- Duke University — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Yubin Kang — Duke University
- Study coordinator: Quinna Lawson
- Email: quinna.marshburn@duke.edu
- Phone: 919-681-3095
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.