Treatment of viral infections using rapidly generated T cells

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 clinical trial aims to evaluate the safety and feasibility of administering rapidly generated virus specific T cells (R-MVST) to patients suffering from refractory viral reactivation or symptomatic disease caused by Epstein-Barr Virus (EBV), cytomegalovirus (CMV), adenovirus (ADV), or BK virus. The R-MVST cells will be produced on-demand from partially HLA-matched healthy donors or the original allo-transplant donor if available. Participants will be closely monitored for potential toxicities, including graft-versus-host disease (GVHD), and the study will assess the impact of R-MVST infusion on viral load, recovery of antiviral immunity, clinical responses, and overall survival. The trial focuses on patients with weakened immune systems who are at risk of severe complications from these viral infections.

Why it matters

Who can join: the full rules

Recipient Inclusion Criteria:

* Men and women ages 18 years or older of all ethnic groups will be eligible for the treatment
* Patients with history of HCT or SOT who demonstrate evidence of viral reactivation and/or infection manifesting as end-organ or systemic disease due to one or more of the following viruses: EBV, CMV, ADV or BK virus and suboptimal response to the standard of care therapy.
* Recurrent or Multiple Viral Infection. RVI defined as occurrence of more than one episode of reactivation that required intervention or symptomatic disease in recipient of allogeneic HCT that required standard of care treatment. MVI defined as more than one virus reactivating (defined by PCR positivity) or causing symptomatic systemic or end-organ disease. At least one of those viral reactivations required standard of care intervention. No standard of care therapy is defined for ADV and BK. Patients with multiple infections/reactivations will be eligible as long as at least one of those viral infections meet the criterium of "refractory".

Recipient Exclusion Criteria:

* Patients with other uncontrolled infections, except for CMV, EBV, ADV or BK. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to the day of infusion. For fungal infections, patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to R-MVST infusion. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection
* Patients who receive corticosteroids at ≥ 0.5mg/kg prednisone or equivalent.
* Patients who received anti-thymocyte globulin (ATG, Alemtuzumab (Campath), or other T-Cell immunosupressive monoclonal antibodies in the last 28 days.
* Patients who received methotrexate, or other antimetabolite-type immunosuppressants that are toxic to proliferating T cells in the last 7 days.
* Patients who received extracorporeal photopheresis within the last 28 days.
* Patients who received checkpoint inhibitor agents (e.g., nivolumab, pembrolizumab, ipilimumab) within 3 drug half-lives of the most recent dose to the infusion of R-MVST.
* Received donor lymphocyte infusion in last 28 days.
* Evidence of GVHD ≥ grade 2
* Evidence of biopsy-proven acute rejection in SOT recipients
* Active and uncontrolled relapse of malignancy
* Patients who are pregnant, or breastfeeding.
* Female of childbearing potential, or male with a female partner of childbearing potential, unwilling to use a highly effective method of contraception.
* Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Patients who have received investigational (IND) product within 14 days of infusion of the the R-MVST cells.

Donor inclusion and exclusion criteria will be followed as per the most current BMT SOP (Donor selection, Donor evaluation and Donor Deferral).

Where it's running

• Columbia University Irving Medical Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Pawel Muranski, MD — Assistant Professor of Medicine and Pathology and Cell Biology
• Study coordinator: Nurse Navigator
• Email: cancerclinicaltrials@cumc.columbia.edu
• Phone: (212) 342 5162

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• R-MVST cell therapy for viral infections in children and young adults

  This will try giving rapidly generated virus-specific T cells (R-MVST) to children and young adults whose weakened immune systems have recurrent or treatment-resistant infections with EBV, CMV, adenovirus, or BK virus.

  Recruiting Phase 1 Columbia University · New York, New York · NCT06926894

• Partially HLA-matched virus-specific T-cell therapy for adenovirus, CMV, or EBV in immunocompromised patients

  This will try partially matched virus-specific T cells to treat adenovirus, CMV, or EBV infections in people whose immune systems are weakened after stem-cell or organ transplants or other immunodeficiencies.

  Recruiting at 2 sites Phase 1/2 Stanford University · Palo Alto, California and 2 other locations · NCT06909110

• Family-donor viral CTLs plus standard care vs standard care alone for refractory ADV or CMV infection after stem cell transplant

  This study tests whether using family-donor virus-specific CTLs in addition to usual treatment helps children, teens, and young adults with hard-to-treat CMV or adenovirus infections after a stem cell transplant.

  Recruiting Phase 3 New York Medical College · Valhalla, New York and 1 other locations · NCT07225972

• CMV-specific T cells after CMV reactivation in adults after HSCT

  This study tests CMV-specific immune recovery in adults who have their first CMV reactivation after an allogeneic HSCT to see how CMV-specific T cells change over time.

  Recruiting The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT07688759

• Biomarkers linked to congenital CMV using newborn blood spots

  Researchers will test protein and RNA markers in dried blood spots from newborns to see if they can identify congenital CMV sequelae early.

  Recruiting at 2 sites Copenhagen University Hospital, Rigshospitalet · Copenhagen and 1 other locations · NCT07635368

• T-cell–guided letermovir stopping after allogeneic stem cell transplant

  This tests whether using a CMV-specific T-cell blood test to decide when adult CMV-positive patients can stop letermovir after allogeneic stem cell transplant keeps them protected while avoiding unnecessary drug exposure.

  Recruiting Phase 4 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Beijing, Beijing Municipality and 11 other locations · NCT07569653

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.