Infusing donor-derived virus-specific T-cells to treat post-transplant viral infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and feasibility of infusing donor-derived, interferon-γ positive selected virus-specific T-cells into patients who have undergone hematopoietic stem cell transplantation and are experiencing treatment refractory viral infections. The approach utilizes the cytokine capture system to select the appropriate T-cells for infusion. The study aims to determine if this method can effectively combat infections caused by adenovirus, cytomegalovirus, and Epstein-Barr virus in these patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Universitätsspital Basel
  Basel, Switzerland Recruiting

Study contacts

• Principal investigator: Nina Khanna, Dr. — Universitätsspital Basel, Klinik für Infektiologie
• Study coordinator: Nina Khanna, MD
• Email: nina.khanna@usb.ch
• Phone: +41-61-2652525 (Zentrale)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.