42 Participants Needed

Viral-Specific T-cell Therapy for Post-Transplant Viral Infections

AS
NS
Overseen ByNaik Swati, MD
Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: St. Jude Children's Research Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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.12345

Why 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?

NS

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

I am of childbearing age and my pregnancy test is negative.
My kidney function, measured by GFR, is above 60 mL/min.
I have a family member who is at least a half match for organ or tissue donation.
See 15 more

Exclusion Criteria

Pregnancy
I am currently experiencing symptoms of graft-versus-host disease.
I am unable to give consent by myself.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CMV- and ADV-specific T-cells infusion to treat infections post-transplant

4 weeks
1 visit (in-person) for infusion

Follow-up

Participants are monitored for safety and effectiveness after treatment, including viral load reduction and adverse events

6 months
Regular visits (in-person) for monitoring

Long-term follow-up

Assess the persistence of response and long-term safety post-infusion

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • VST
Trial Overview The study is testing if T-cells from donors can fight off stubborn CMV and ADV infections in post-transplant patients. These special cells are selected using an automated device called CliniMACS. The main goal is to see if the virus levels drop significantly within four weeks after getting these T-cells.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Cohort BExperimental Treatment2 Interventions
Group II: Cohort AExperimental Treatment2 Interventions

VST is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as VSTs for:
🇪🇺
Approved in European Union as VSTs for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials
451
Recruited
5,326,000+

Published Research Related to This Trial

Adoptive transfer of donor-derived virus-specific T cells (VSTs) has shown effectiveness in restoring immunity against viral infections after hematopoietic stem cell transplantation (HSCT), with success rates of 70% to 90% in recipients.
Recent studies have also demonstrated that using closely matched third-party VSTs can provide protection, achieving response rates of 60% to 70%, which is crucial for patients with virus-naïve donors.
T cells for viral infections after allogeneic hematopoietic stem cell transplant.Bollard, CM., Heslop, HE.[2021]
A third-party virus-specific T cell (VST) bank was successfully established using discarded white cells from blood donors, showing significant cytotoxicity against multiple viruses like Adenovirus and Cytomegalovirus, which are often difficult to treat.
The study demonstrated that a carefully selected combination of just 6 VST lines could provide coverage for 99% of potential recipients in a multi-ethnic Asian population, indicating a cost-effective approach to enhance treatment options for opportunistic viral infections.
A cost-effective strategy for selection of third-party donors for a virus-specific T-cell bank for an Asian patient population.Linn, YC., Sundar Raj, K., Teo, B., et al.[2023]
Adoptive immunotherapy using virus-specific T cells (VSTs) has been shown to be a safe and effective treatment for viral infections in patients who have undergone hematopoietic stem cell transplantation (HSCT), with minimal toxicity and a low risk of graft versus host disease.
VSTs have demonstrated efficacy against several viral infections, including cytomegalovirus and Epstein-Barr virus, highlighting their potential as a therapeutic option during the immune deficient period following HSCT.
Applications of virus-specific T cell therapies post-BMT.Motta, CM., Keller, MD., Bollard, CM.[2023]

Citations

Virus-Specific T-Cell Therapy for Prophylaxis and Treatment of ...Multicenter study of banked third-party virus-specific T cells to treat severe viral infections after hematopoietic stem cell transplantation.
Third-party virus-specific T cells for the treatment of double- ...Virus-specific T cells (VSTs) have been shown to be an effective treatment for infections with ADV, BKPyV, cytomegalovirus (CMV), and Epstein-Barr virus (EBV).
Compassionate access to virus-specific T cells for adoptive ...These results show that the compassionate use of virus-specific T cell therapy can provide therapeutic benefit, especially for patients with ...
Role of Virus-Specific T Cell Therapy for Cytomegalovirus...In this article, we review the emerging role of virus-specific T cell therapy in the management of CMV and BKV after kidney transplantation.
Outcomes following posttransplant virus-specific T-cell ...Virus-specific T cells are safe in patients with SCD following hematopoietic stem cell transplant. In patients with active viremia, 80% achieved remission ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36736781/
Third-Party and Patient-Specific Donor-Derived Virus ...Both donor-derived (DD) and third-party (TP) virus-specific T cells (VSTs) have shown efficacy and safety in viral management following HSCT in ...
Outcomes following posttransplant virus-specific T-cell therapy ...Here, we report the outcomes of patients with SCD at a single-center who received VSTs after transplant to prevent or treat viral infections.
Virus-specific T cell therapy to treat refractory viral ...This minireview will explore challenges and controversies in treating viral OIs, competing VST production methods, recently reported and ongoing clinical ...
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