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NCT06011486

Expansion of Virus-Specific Lymphocytes for Cell Therapy

Recruiting now Phase 1 Last updated 24 October 2024
What this trial tests

Phase 1 trial testing Lymphocyte infusion (ImmuneCellVir-I) in CMV Viremia in 10 participants. Currently enrolling.

Timeline
10 June 2024
Primary endpoint
10 June 2025
10 June 2026

Quick facts

Lead sponsorHospital Israelita Albert Einstein
PhasePhase 1
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment10
Start date10 June 2024
Primary completion10 June 2025
Estimated completion10 June 2026
Sites1 location across Brazil

Drugs / interventions tested

Conditions studied

Sponsor

Hospital Israelita Albert Einstein

Who can join

Adults 18 to 75, any sex, with CMV Viremia or CMV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Infections and reactivation of human cytomegalovirus (CMV), adenovirus, Epstein-barr and polyoma virus infections are frequent causes of morbidity and mortality and are a source of serious complications in patients undergoing allogeneic bone marrow transplantation. In this project we will prepare specific T lymphocytes from blood donor, select cells CMV-specific by interferon gamma capture and treat patients with CMV viral infections. These cells will be used as antiviral therapy in transplanted patients whom do not respond to conventional therapies or in patients whose conventional therapy may be toxic in the context of transplantation. In this context, CMV reactivation can lead to serious complications in patients, such as irreversible neurological changes, pulmonary, gastrointestinal and ophthalmologic complications, among others, in addition to prolonged hospitalizations, leading to significant morbidity and mortality , both in the health sector public as private. This project may represent an important therapeutic modality using cell of the shelf as a source of therapy for different patients and contributing to reduced morbidity / mortality after transplantation, as well as a reduction in the hospitalization period.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Advancing cell-based therapy in sepsis: An anesthesia outlook.
    Ye H, Zou X, Fang X. · · 2024 · cited 2× · PMID 38708689 · DOI 10.1097/cm9.0000000000003097

Verify or expand the search:

Other recruiting trials for CMV Viremia

Currently open trials in the same condition.

Other Hospital Israelita Albert Einstein trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing