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®

NCT02007356 | Recruiting Phase 2 DMC

• 1 other identifier: EKBB 205/13; me12Khanna
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Adenovirus Infection; EBV; Cytomegalovirus Infections; Cytokine Capture System; Allogenic Disease

Outcome Measures

Primary Outcomes (1)

• Level of enriched IFN-γ+ T-cells

  7 days

Secondary Outcomes (1)

• Treatment efficacy

  7 days

Study Arms (1)

allogeneic HSCT

EXPERIMENTAL

The present study will evaluate and validate in a single-center, open-label, single arm fashion the safety and feasibility of direct infusions of donor-derived pathogen-specific IFN-γ positive T-cells in recipients of HSCT with post-transplant viral infection according to the previously clinically certified CCS® \[3-6\]. The Investigator will first generate and apply IFN-γ positive selected T-cells to recipients of HSCT with CMV, EBV or adenovirus as previously published. The Investigator aim is to include 6 patients from the University Hospital of Basel. With confirmed safety the investigator will in the future perform an efficacy study and extend this treat-ment for other clinically relevant pathogens including human herpesvirus (HHV)-6, HHV-8, polyomaviruses JC and BK and fungi including Aspergillus fumigatus and Candida albicans, to other immunosuppressed patients such as solid organ transplant (SOT) recipients.

Biological: IFN-γ positive selected T-cells

Interventions

IFN-γ positive selected T-cells BIOLOGICAL

allogeneic HSCT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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
• Or if antiviral treatment is contraindicated
• Patient with EBV:
• \. 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:

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Universitätsspital Basel

Basel, 4031, Switzerland

RECRUITING

Related 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.

  PMID: 15134189 BACKGROUND

MeSH Terms

Conditions

Adenoviridae Infections; Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

DNA Virus Infections; Virus Diseases; Infections; Herpesviridae Infections

Study Officials

• Nina Khanna, Dr.

  Universitätsspital Basel, Klinik für Infektiologie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nina Khanna, MD

CONTACT

+41-61-2652525 (Zentrale); nina.khanna@usb.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 10, 2013
• Study Start: December 1, 2014
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)