R-MVST Cells for Viral Infections

Phase 1

Recruiting

Led By Pawel Muranski, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year after the initial r-mvst infusion

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a cell therapy called R-MVST for safety and feasibility in patients with refractory viral reactivation and/or symptomatic disease caused by Epstein Barr Virus (EBV), cytomegalovirus (CMV), adenovirus (ADV) or BK virus. The cell therapy will be generated on-demand from the closest partially human leukocyte antigen (HLA)-matched (minimum haploidentical) healthy donors or from the original allo-transplant donor if available.

Who is the study for?

This trial is for adults who've had a transplant and are struggling with tough-to-treat viral infections like EBV, CMV, ADV, or BK virus. They should have tried standard treatments without enough success. It's not open to people under 18 or those with conditions that don't match the study's focus.

What is being tested?

The trial tests R-MVST cells made from donors' immune cells matched to patients at least by half (haploidentical) or from the original donor of their transplant. The goal is to see if these cells can safely fight off stubborn viruses in patients where usual treatments haven't worked well.

What are the potential side effects?

Possible side effects include reactions related to the immune system such as graft-versus-host disease (GVHD), where donated immune cells attack the patient’s body tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I had a transplant and now have a virus affecting my body because standard treatments didn't work well.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year after the initial r-mvst infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year after the initial r-mvst infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year after the initial r-mvst infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of GVHD post-infusion that leads to safety endpoint

Incidence of toxicity that leads to safety endpoint

Secondary study objectives

Incidence of secondary graft failure

Overall survival rate

Percentage of subjects with good response in viral load or end-organ disease improvement

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group B: Solid organ transplant recipients (SOT)Experimental Treatment1 Intervention

In SOT recipients, the study will use higher doses of R-MVST cells, as the infused anti-viral T cells are less likely to persist long-term and cause GVHD, based on the safety profile of PyVST cells used for therapy of PML in non-HCT subjects. Subjects will receive a single dose of R-MVST Cells, and followed for toxicity and GVHD for 28 days days after infusion. Up to two additional doses may be administered, minimum of 28 days apart if cohort safety is established and reinfusion criteria are met. A new 28-day safety-monitoring period will ensue for each additional infusion. Subjects will be followed for possible virological and clinical responses for up to 1 year after the initial R-MVST infusion.

Group II: Group A: Allogenic Stem Cell Transplant Recipient (SCT)Experimental Treatment1 Intervention

Dose levels selected for Group A are based on previous experience with VST cells in HCT recipients and are lower than in Group B (SOT recipients), as donor-derived R-MVST cells are more likely to persist in recipients of HCT from the same donors. Thus, there is theoretically a higher risk for development of GVHD in this subset of patients. Each group will undergo independent dose escalation. Subjects will receive a single dose of R-MVST Cells, and followed for toxicity and GVHD for 28 days days after infusion. Up to two additional doses may be administered, minimum of 28 days apart if cohort safety is established and reinfusion criteria are met. A new 28-day safety-monitoring period will ensue for each additional infusion. Subjects will be followed for possible virological and clinical responses for up to 1 year after the initial R-MVST infusion.

0 / 1Eligibility criteria met