Viral-Specific T-cell Therapy for Post-Transplant Viral Infections
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called VST (Virus-Specific T-cells), which uses special T-cells to combat viral infections like CMV and ADV in patients who have undergone a stem cell transplant. The goal is to determine if these T-cells can reduce the virus in the blood and aid in safer, more effective recovery. The trial seeks patients who have had a transplant and still experience these infections despite treatment. Participants should not have severe infections or conditions requiring intensive medical support. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on steroids greater than 0.5 mg/kg prednisone equivalent, you may not be eligible to participate.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that special immune cells, called virus-specific T cells (VSTs), have been safely used in other studies to treat viral infections after stem cell transplants. For instance, patients who received these cells for CMV, a common virus that can be dangerous post-transplant, experienced good results with few safety issues. Patients have tolerated these cells well, whether from donors or other sources.
In another study, VSTs helped patients with various viral infections, yielding promising results. The treatment was generally safe, with few serious side effects reported. This suggests that VSTs offer a promising option for safely managing challenging viral infections after a transplant. While no treatment is without risks, existing evidence indicates that patients in similar situations have tolerated VSTs well.12345Why do researchers think this study treatment might be promising?
Researchers are excited about Viral-Specific T-cell Therapy (VST) because it offers a personalized approach to fighting post-transplant viral infections. Unlike traditional antiviral medications, which broadly target viruses, VST harnesses the power of the immune system by using T-cells specifically trained to recognize and attack virus-infected cells. This targeted action not only promises more effective viral control but also reduces the risk of harming healthy cells, potentially leading to fewer side effects. Additionally, VST could provide a solution for patients who do not respond well to standard antiviral treatments or who experience frequent relapses.
What evidence suggests that VSTs might be an effective treatment for post-transplant viral infections?
Research has shown that special immune cells called virus-specific T-cells (VSTs) can help treat viral infections like CMV and ADV after a transplant. In this trial, participants will be divided into two cohorts to receive VSTs. One study found that 80% of patients with active viral infections improved after receiving VSTs. These T-cells directly attack the viruses, reducing the virus levels in the body. Another study also found that VSTs are effective against several viruses, including CMV and ADV. Overall, VSTs have strong potential to reduce infections in transplant patients.15678
Who Is on the Research Team?
Naik Swati, MD
Principal Investigator
St. Jude Children's Research Hospital
Are You a Good Fit for This Trial?
This trial is for patients who've had a specific type of bone marrow transplant and are struggling with CMV or ADV infections that haven't improved after two weeks of standard treatment. They should not have active GVHD, recent donor lymphocyte infusions, or be on high-dose steroids. Women must test negative for pregnancy and all participants need functioning major organs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CMV- and ADV-specific T-cells infusion to treat infections post-transplant
Follow-up
Participants are monitored for safety and effectiveness after treatment, including viral load reduction and adverse events
Long-term follow-up
Assess the persistence of response and long-term safety post-infusion
What Are the Treatments Tested in This Trial?
Interventions
- VST
VST is already approved in United States, European Union for the following indications:
- Cytomegalovirus (CMV) infections after hematopoietic cell transplantation
- Adenovirus (ADV) infections after hematopoietic cell transplantation
- Cytomegalovirus (CMV) infections after hematopoietic cell transplantation
- Adenovirus (ADV) infections after hematopoietic cell transplantation
Find a Clinic Near You
Who Is Running the Clinical Trial?
St. Jude Children's Research Hospital
Lead Sponsor