← Back to Search

Virus Therapy

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

Phase 2

Recruiting

Led By Ashok Srinivasan, MD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours after infusion

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if donor T-cells can safely treat CMV & ADV infections post-transplant. The primary objective is to reduce viral load & secondary is to measure safety & long-term response.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the document doesn't specify side effects, similar treatments often include risks like infusion reactions, increased infection risk due to immune response changes, potential organ inflammation, and general discomfort at the infusion site.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours after infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours after infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours after 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

Degree of reduction of CMV and/or ADV viral load

Secondary study objectives

Incidence of AEs related to grade 3-4 cytokine release syndrome (CRS), or grade 1-2 CRS persist beyond 72 hours despite therapy

Incidence of Grade 3-4 GVHD

Incidence of Grade 3-4 Neurotoxicity of any duration

+5 more

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: Cohort BExperimental Treatment2 Interventions

Cohort B will include haploidentical donor who is different from the stem cell donor

Group II: Cohort AExperimental Treatment2 Interventions

Cohort A will include haploidentical donor who is identical to the stem cell donor. The first 5 patients will be enrolled in Cohort A. If safety criteria are met, cohort B will be open for enrollment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CliniMACS

2005

Completed Phase 3

~770

Do I qualify?Apply below to find out