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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06439173
Other study ID # PI23/01107
Secondary ID PI2024 03 1552
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date December 31, 2026

Study information

Verified date May 2024
Source Instituto de Investigación Biomédica de Salamanca
Contact Fermín Sánchez-Guijo Martín, PhD MD
Phone +34 923 291384
Email ferminsg@usal.es
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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-T/tumor 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 31, 2026
Est. primary completion date June 30, 2026
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with diffuse large B-cell lymphoma undergoing consecutive commercial CAR-T therapy - Over 18 years old - Sign the informed consent Exclusion Criteria: - Under 18 years old - Do not sign the informed consent

Study Design


Intervention

Biological:
CAR-T cell therapy
Patients with diffuse large B-cell lymphoma undergoing consecutive commercial CAR-T therapy at the University Hospital of Salamanca

Locations

Country Name City State
Spain Complejo Asistencial Universitario de Salamanca Salamanca

Sponsors (2)

Lead Sponsor Collaborator
Instituto de Investigación Biomédica de Salamanca Carlos III Health Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Characterizing hematopoietic niche post CAR-T Therapy To analyze the characteristics of the hematopoietic niche in patients experiencing prolonged cytopenias post CAR-T cell therapy compared to those without cytopenias and their pre-treatment status. 36 months
Primary Characterizing systemic inflammation post CAR-T Therapy To analyze the characteristics of systemic inflammatory status in patients experiencing prolonged cytopenias post CAR-T cell therapy compared to those without cytopenias and their pre-treatment status. 36 months
Primary Characterizing medullary inflammation post CAR-T Therapy To analyze the characteristics of medullary inflammatory status in patients experiencing prolonged cytopenias post CAR-T cell therapy compared to those without cytopenias and their pre-treatment status. 36 months
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