Viral infections in immunocompromised patients.
Janet Englund, Tobias Feuchtinger, Per Ljungman
https://pubmed.ncbi.nlm.nih.gov/21195305Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID05183490
Phase I Study of Adoptive Immunotherapy with Rapidly Generated Virus Specific T Cells for Refractory Viral Infections
Led by Columbia University · Updated on 2024-12-30
36
Participants Needed
1
Research Sites
52 weeks
Total Duration
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AI-Summary
What this Trial Is About
This research aims to evaluate the safety and feasibility of using rapidly generated virus specific T (R-MVST) cells to treat patients with difficult-to-treat viral infections caused by Epstein Barr Virus (EBV), cytomegalovirus (CMV), adenovirus (ADV), or BK virus. These viruses can reactivate in people with weakened immune systems, such as those who have undergone stem cell or solid organ transplants, or those receiving immunosuppressive therapies. The study focuses on patients whose viral infections have not responded well to standard treatments. Participants will receive R-MVST cells made from a closely matched healthy donor or the original transplant donor. Two groups receive different dosing levels: Group A includes stem cell transplant recipients, who get lower doses due to a higher risk of graft-versus-host disease (GVHD), and Group B includes solid organ transplant recipients, who receive higher doses. Each participant receives one dose initially, with the option for up to two additional doses spaced at least 28 days apart if safety criteria are met. Following each infusion, patients are monitored closely for 28 days to watch for toxicities and GVHD. The study follows participants for up to one year to observe viral response and overall health outcomes. During the study, participants undergo careful monitoring including evaluation of toxicities, graft-versus-host disease, and viral load changes. Researchers assess safety outcomes mainly within the first 28 days after infusion and track longer-term effects such as survival and recovery of antiviral immunity for up to one year. The study also checks for any secondary failure of the transplanted cells 28 days after treatment. This comprehensive follow-up helps determine how well the R-MVST cells work and their safety profile in treating these viral infections.
CONDITIONS
Brief Title
R-MVST Cells for Treatment of Viral Infections
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Men and women ages 18 years or older of all ethnic groups
- History of hematopoietic stem cell transplant (HCT) or solid organ transplant (SOT)
- Evidence of viral reactivation or infection causing end-organ or systemic disease due to EBV, CMV, adenovirus, or BK virus
- Suboptimal response to standard therapy for viral infection
- Recurrent or multiple viral infections with at least one refractory to standard treatment
You will not qualify if you...
- Uncontrolled infections other than CMV, EBV, adenovirus, or BK virus
- Receiving corticosteroids at 0.5mg/kg prednisone or higher
- Received anti-thymocyte globulin, Alemtuzumab, or similar immunosuppressive antibodies within 28 days
- Received methotrexate or other toxic immunosuppressants within 7 days
- Received extracorporeal photopheresis within 28 days
- Received checkpoint inhibitors within 3 drug half-lives before infusion
- Donor lymphocyte infusion within 28 days
- Graft-versus-host disease grade 2 or higher
- Biopsy-proven acute rejection in solid organ transplant recipients
- Active, uncontrolled cancer relapse
- Pregnant or breastfeeding
- Unwilling to use effective contraception if of childbearing potential
- Uncontrolled illness affecting compliance
- Received investigational products within 14 days before infusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Initial infusion plus up to two additional infusions, each followed by 28-day safety monitoring periods
Participants receive a single dose of rapidly generated virus specific T (R-MVST) cells to treat viral infections related to immunosuppression. Up to two additional doses may be given at least 28 days apart if safety criteria are met.
1 to 3 infusions with 28-day safety-monitoring visits after each infusion
Follow-up
Duration - Up to 1 year after the initial infusion
Participants are followed for up to 1 year after the initial R-MVST infusion to monitor virological and clinical response, overall survival, and potential late adverse effects.
Regular follow-up visits over 1 year
Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
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Research Team
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/28209721