A Study to Assess Safety and Feasibility of Direct Infusions of Donor-derived Virus-specific T-cells in Recipients of Hematopoietic Stem Cell Transplantation With Post-transplant Viral Infections Using the Cytokine Capture System®

Cytomegalovirus Infections Clinical Trial

— CCS  

Official title:

A Phase I/II Single-center Study to Assess Safety and Feasibility of Direct Infusions of Donor-derived Virus-specific T-cells in Recipients of Hematopoietic Stem Cell Transplantation With Post-transplant Viral Infections Using the Cytokine Capture System®

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02007356
• Other study ID #: EKBB 205/13; me12Khanna
• Status: Recruiting
• Phase: Phase 2
• Start date: December 2014
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Nina Khanna, MD
• Phone: +41-61-2652525 (Zentrale)
• Email: nina.khanna[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the feasibility of donor-derived interferon (IFN)-γ positive select-ed virus-specific T-cells using the cytokine capture system® (CCS) and the safety of subsequent infusion in recipients of hematopoietic stem cell transplantation (HSCT) with treatment refractory post-transplant viral infections. The CCS has already been successfully used in clinical studies in Germany and United Kingdom (UK).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adults > 18 years of age
• Undergone allogeneic HSCT
• Written informed consent
• Patients with treatment refractory infections with adenovirus, cytomegalovirus (CMV) or Epstein-Barr virus (EBV) will be included in case of fulfilling following criteria:

Patient with Adenovirus Infection:

1. Antiviral treatment with cidofovir for at least 7 days

• no virus load decrease ( = 1 log) or virus load increase on treatment for at least 7 days or
• cluster of differentiation 3 (CD3) + cells < 300/µL on treatment for at least 7 days

2. Or if antiviral treatment is contraindicated

Patient with EBV:

1. After receipt of at least one anti-cluster of differentiation 20 antigen (CD20)-antibody treat-ment (375 mg/m2)

• No Virus load decrease (= 1 log) or virus load increase 7 days after receipt of treatment or
• CD3+ cells < 300/µL 7 days after receipt of treatment or
• Clinical progression

Patient with CMV:

1. Antiviral treatment with ganciclovir or foscavir for 14 days

• No Virus load decrease (= 1 log) or virus load increase on day 14

2. Or if > 2 recurrences despite antiviral treatment with ganciclovir or foscavir for 14 days and CD3+ cells < 300/µL

3. Or if antiviral treatment is contraindicated -

Patient Exclusion Criteria:

• graft-versus-host disease (GVHD) > grade 2 at the time point of planned infusion
• Known allergy to iron-dextran or murine antibodies

Related Conditions & MeSH terms

• Adenoviridae Infections
• Adenovirus Infection
• Allogenic Disease
• Communicable Diseases
• Cytokine Capture System
• Cytomegalovirus Infections
• EBV
• Infections
• Virus Diseases

Intervention

Biological:
• IFN-? positive selected T-cells

Locations

Country	Name	City	State
Switzerland	Universitätsspital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Kaufmann GR, Khanna N, Weber R, Perrin L, Furrer H, Cavassini M, Ledergerber B, Vernazza P, Bernasconi E, Rickenbach M, Hirschel B, Battegay M; Swiss HIV Cohort Study. Long-term virological response to multiple sequential regimens of highly active antiretroviral therapy for HIV infection. Antivir Ther. 2004 Apr;9(2):263-74. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of enriched IFN-?+ T-cells		7 days
Secondary	Treatment efficacy	Treatment efficacy defined as reduction of virus load, in vivo expansion of antigen-specific T cells in peripheral blood as well as reduction of clinical signs of specific viral infection	7 days