R-MVST Cells for Viral Infections

Recruiting at 1 trial location

Overseen By Prakash Satwani, MD

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Columbia University

Must not be taking: Corticosteroids, Antimetabolites, Checkpoint inhibitors, others

Disqualifiers: Uncontrolled infections, GVHD, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 28 days

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety of R-MVST cells, special immune cells designed to combat difficult viral infections. It targets individuals with persistent viral infections such as EBV, CMV, adenovirus, or BK virus, which can lead to serious health issues if not effectively treated. Participants may qualify if they have undergone a stem cell or organ transplant and are dealing with recurring viral infections that resist standard treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, certain medications like corticosteroids at high doses, specific immunosuppressants, and investigational products must not have been taken recently. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that R-MVST cells are likely to be safe for humans?

Research has shown that R-MVST cells have been tested in earlier studies to assess their safety for humans. These cells are designed to combat certain viruses, such as Epstein-Barr virus (EBV) and cytomegalovirus (CMV). In these studies, recipients of R-MVST cells generally tolerated the treatment well, with few serious side effects reported and most patients experiencing no severe negative reactions.

The treatment is in its early testing phase, focusing primarily on safety. So far, no major safety concerns have emerged. Researchers are closely monitoring the treatment to identify any potential problems early. R-MVST cells are being tested in individuals with weakened immune systems, making safety checks crucial. Overall, the treatment appears safe, but it is still under careful study to confirm this. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about R-MVST Cells because they offer a new approach to treating viral infections in immunocompromised patients, like those who have received transplants. Unlike traditional antiviral drugs, which can have limited effectiveness and significant side effects, R-MVST Cells are a type of immune cell therapy designed to specifically target and fight multiple viruses such as cytomegalovirus, Epstein-Barr virus, adenovirus, and BK virus. This targeted action could lead to more effective and safer outcomes, providing a promising alternative to current treatment options. Plus, this cell therapy might offer quicker results, which is crucial for patients with weakened immune systems.

What evidence suggests that R-MVST cells might be an effective treatment for viral infections?

Research has shown that virus-specific T cells, such as those used in R-MVST treatment, effectively treat multiple viral infections in patients with weakened immune systems. Previous patients demonstrated promising responses against viruses like cytomegalovirus (CMV), Epstein-Barr virus (EBV), and adenovirus. In this trial, participants will be divided into groups based on their transplant status or immunocompromised condition. These T cells specifically target and fight viruses, aiding the body's immune recovery. Initial findings suggest that R-MVST cells can reduce the viral load and improve overall health outcomes for patients facing these challenging infections. The treatment aims to boost antiviral immunity, offering hope for those struggling with persistent viral infections. ^{1 3 5 6 7}

Who Is on the Research Team?

Prakash Satwani, MD

Principal Investigator

Professor of Pediatrics

Are You a Good Fit for This Trial?

This trial is for children and young adults with stubborn viral infections like CMV, EBV, ADV, or BK virus. Participants must have a matching healthy donor available for T-cell donation. They should not have conditions that could worsen with the treatment.

Inclusion Criteria

I have a history of transplant and my body is fighting a virus infection poorly despite treatment.

I am between 3 months and 25 years old.

I've had multiple or recurrent viral infections after a stem cell transplant.

Exclusion Criteria

Patients who have received investigational (IND) product within 14 days of infusion of the R-MVST cells

My cancer is currently getting worse and not under control.

I cannot or do not want to get treatments at Morgan Stanley Children's Hospital.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive R-MVST cell infusions to treat viral infections

Up to 28 days

Multiple visits for infusion and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including incidence of GVHD and other toxicities

Up to 1 year

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• R-MVST Cells

Trial Overview The study tests R-MVST cells to treat persistent viral infections. These special immune cells are made quickly from donors who partially match the patient's tissue type and are monitored for safety and effectiveness against the viruses.

How Is the Trial Designed?

Group I: Group C: Other Immunocompromised Patients Experimental Treatment 1 Intervention

Patients who have infection due to cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus or BK virus, and are immunocompromised for reasons other than hematopoietic stem cell transplant or solid organ transplant.

Group II: Group B: Solid Organ Transplant Recipients Experimental Treatment 1 Intervention

Patients who have infection due to cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus or BK virus, and are recipients of solid organ transplant.

Group III: Group A: Allogenic Stem Cell Transplant Recipients Experimental Treatment 1 Intervention

Patients who have infection due to cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus or BK virus, and are recipients of hematopoietic stem cell transplant.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Published Research Related to This Trial

In a phase 1 trial involving three children with relapsed or resistant neuroblastoma, engineered NKT cells showed promising safety, with no dose-limiting toxicities observed after infusion, despite some hematologic adverse events linked to pre-treatment conditioning.

One patient experienced a significant anti-tumor response, with regression of bone metastatic lesions, indicating that CAR-NKT cells can effectively target tumors and expand in the body after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-GD2 CAR-NKT cells in patients with relapsed or refractory neuroblastoma: an interim analysis. Heczey, A., Courtney, AN., Montalbano, A., et al.[2023]

The administration of autologous invariant natural killer T (iNKT) cells in 10 patients with advanced hepatocellular carcinoma was found to be safe and well-tolerated, with no severe adverse events reported, even at high doses (up to 1×10^10 cells).

Expanded iNKT cells showed a strong T-helper 1-like immune response, producing significant amounts of cytokines associated with antitumor activity, suggesting potential effectiveness in treating hepatocellular carcinoma, warranting further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adoptive Transfer of Autologous Invariant Natural Killer T Cells as Immunotherapy for Advanced Hepatocellular Carcinoma: A Phase I Clinical Trial. Gao, Y., Guo, J., Bao, X., et al.[2021]

A systematic analysis of CAR T-cell therapy adverse events revealed 5,112 reports of hematotoxicity, highlighting significant under-reporting of severe conditions like hemophagocytic lymphohistiocytosis (HLH) and disseminated intravascular coagulation (DIC), which have high mortality rates of 69.9% and 59.6%, respectively.

The study identified 23 hematologic adverse events that were significantly over-reported compared to the general database, emphasizing the need for increased awareness and monitoring of these rare but potentially fatal toxicities in CAR T therapy patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemophagocytic lymphohistiocytosis and disseminated intravascular coagulation are underestimated, but fatal adverse events in chimeric antigen receptor T-cell therapy. Song, Z., Tu, D., Tang, G., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05183490

R-MVST Cells for Treatment of Viral Infections The main purpose of this study is to test whether giving an experimental cell product can treat the viral infection in patients who have conditions that cause ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06926894

R-MVST Cells for Treatment of Viral Infections in Children ... The main purpose of this study is to test whether giving an experimental cell product can treat the viral infection in patients who have conditions that cause ...

3. withpower.com withpower.com/trial/phase-1-infections-2022-3a905

R-MVST Cells for Viral Infections Research shows that virus-specific T cells, like those used in R-MVST treatment, have been effective in treating multiple viral infections in patients with ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5662844/

Off-the-Shelf Virus-Specific T Cells to Treat BK Virus, Human ... Treatment outcomes in patients infected with cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus, and human herpesvirus 6 (HHV-6).

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05183490/r-mvst-cells-for-treatment-of-viral-infections

R-MVST Cells for Treatment of Viral Infections The primary objective is to determine the safety and feasibility of administering R-MVST cells to patients with refractory viral ...

6. trialx.com trialx.com/clinical-trials/listings/313131/r-mvst-cells-for-treatment-of-viral-infections-in-children-and-young-adults/

R-MVST Cells for Treatment of Viral Infections in Children ... The main purpose of this study is to test whether giving an experimental cell product can treat the viral infection in patients who have ...

7. amjtransplant.org amjtransplant.org/article/S1600-6135(24)00347-2/fulltext

Virus-specific T cell therapy to treat refractory viral ... Virus-specific T cell therapies aim to restore host-specific immunity to opportunistic viruses that is lacking due to ongoing immunosuppressive therapy.