NCT06439173 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
| NCT ID | NCT06439173 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto de Investigación Biomédica de Salamanca |
| Condition | Diffuse Large B Cell Lymphoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2024-01-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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-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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06439173 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diffuse Large B Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06439173 currently recruiting?
Yes, NCT06439173 is actively recruiting participants. Contact the research team at ferminsg@usal.es for enrollment information.
Where is the NCT06439173 trial being conducted?
This trial is being conducted at Salamanca, Spain.
Who is sponsoring the NCT06439173 clinical trial?
NCT06439173 is sponsored by Instituto de Investigación Biomédica de Salamanca. The trial plans to enroll 40 participants.