Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Viral Specific T-Lymphocytes for Adenovirus, CMV or EBV Infections in Immunocompromised Patients
NCT04364178Phase 2
Key facts
- Status
- Terminated
- Start
- Aug 2020
- Primary completion
- Feb 2023
- Countries
- 1
- Modality
- Adoptive Cell Transfer
- Conditions
- adenovirus infectioncytomegalovirus infection (CMV)Epstein-Barr virus infection
01
Overview
Phase 2, open-label, single-arm trial of virus-specific T cells in adenovirus infection, cytomegalovirus infection (CMV) and Epstein-Barr virus infection. Primary endpoints: Number of Patients With Grade III-IV Acute Graft Versus Host Disease at 90 days and Number of Patients Who Experienced Grade 4/5 Adverse Events After Infusion at 90 days. Started Aug 2020; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Viral Specific T-Lymphocytes
Infusion of Adenovirus, CMV, or EBV specific T-lymphocytes generated via cytokine capture system.
03
Who it enrols
Patients aged 1 month to 65 years with prior allogeneic HCT, solid organ transplant, primary immunodeficiency, or immunosuppressive therapy, who have a diagnosis of Adenovirus, CMV, or EBV infection persistent despite standard therapy.
04
Endpoints
Primary
Number of Patients With Grade III-IV Acute Graft Versus Host Disease
Number of Patients Who Experienced Grade 4/5 Adverse Events After Infusion
Secondary
Number of Patients Who Reached 6 Month Survival
Number of Patients Who Achieved One Year Survival
Patients Who Achieved Viral Response (Complete Response) to Treatment
Number of Days to Patient Complete Response to Viral Specific Infusion
Number of Days Post-VST Infusion Upon Which Viral Specific Antimicrobial Treatment Was Discontinued
Number of Days Post VST Infusion That Patients Achieved T Cell Immune Reconstitution
Beyond the preview
Go deeper on NCT04364178.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT04364178.