Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06439173
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-04-18
Brief Title:
Study of the Hematopoietic Niche and the Role of Inflammation in the Pathophysiology of Cytopenias After CAR-T Cell Therapy Potential of Therapies Directed to Repair the Bone Marrow Microenvironment
Sponsor:
Instituto de Investigación Biomédica de Salamanca
Organization:
Instituto de Investigación Biomédica de Salamanca
Study Overview
Official Title:
Study of the Hematopoietic Niche and the Role of Inflammation in the Pathophysiology of Cytopenias After CAR-T Cell Therapy Potential of Therapies Directed to Repair the Bone Marrow Microenvironment
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Immunotherapy with chimeric antigen receptor T-cells CAR-T has revolutionized the treatment of oncohematological diseases and its applications in solid tumors and non-neoplastic diseases are advancing Cytopenias after CAR-T therapy are the most frequent complication in the medium and long term after treatment they are a cause of morbimortality and there are no effective therapies available
The general objective of the present research project is to analyze in a series of 40 patients with diffuse large B-cell lymphoma undergoing consecutive commercial CAR-T therapy at the University Hospital of Salamanca the characteristics of the hematopoietic niche and the systemic and bone marrow inflammatory status in patients with prolonged cytopenias after CAR-T cell therapy with respect to those without cytopenias and with respect to the pre-treatment situation performing quantitative and functional analysis of the stroma by immunohistochemistry flow cytometry and genomic studies in addition to functional hematopoietic assays-clonogenic assays long-term cultures- and to evaluate both in vitro by co-culturing with macrophages activated by CAR-Ttumor cell interaction and assessing cytokines and in vivo in an animal model of lymphoma and CRS the therapeutic potential of therapies aimed at repairing the hematopoietic bone marrow microenvironment such as the use of allogeneic mesenchymal cells MSC from healthy donors and MSC-derived extracellular vesicles MSC-EV studying their effects on inflammatory mediators hematopoiesis and the cytotoxic effect of CAR-T
The general objective of the present research project is to analyze in a series of 40 patients with diffuse large B-cell lymphoma undergoing consecutive commercial CAR-T therapy at the University Hospital of Salamanca the characteristics of the hematopoietic niche and the systemic and bone marrow inflammatory status in patients with prolonged cytopenias after CAR-T cell therapy with respect to those without cytopenias and with respect to the pre-treatment situation performing quantitative and functional analysis of the stroma by immunohistochemistry flow cytometry and genomic studies in addition to functional hematopoietic assays-clonogenic assays long-term cultures- and to evaluate both in vitro by co-culturing with macrophages activated by CAR-Ttumor cell interaction and assessing cytokines and in vivo in an animal model of lymphoma and CRS the therapeutic potential of therapies aimed at repairing the hematopoietic bone marrow microenvironment such as the use of allogeneic mesenchymal cells MSC from healthy donors and MSC-derived extracellular vesicles MSC-EV studying their effects on inflammatory mediators hematopoiesis and the cytotoxic effect of CAR-T
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PI2024 03 1552 | REGISTRY | Ethics Committee for Drug Research of the Salamanca Health Area | None |