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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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Degree of reduction of CMV and/or ADV viral load
Secondary outcome measures
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 moreTrial 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
Find a Location
Who is running the clinical trial?
St. Jude Children's Research HospitalLead Sponsor
428 Previous Clinical Trials
5,306,549 Total Patients Enrolled
Ashok Srinivasan, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
5 Previous Clinical Trials
464 Total Patients Enrolled
Naik Swati, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My bilirubin is ≤ 2.5mg/dL and my ALT is ≤ 5 times the normal upper limit.My lung function is good, or I can breathe well without extra oxygen.I am currently experiencing symptoms of graft-versus-host disease.I have not had a Donor Lymphocyte Infusion in the last 4 weeks.I do not have graft-versus-host disease.I am not pregnant or breastfeeding.I have a half-matched donor for a specific cell therapy.I, or my guardian, can sign the consent form.I am unable to give consent by myself.I have received Thymoglobulin or Alemtuzumab within the last 30 days.I have not received a donor lymphocyte infusion in the last 4 weeks.I had a stem cell transplant and have CMV or ADV not responding to antiviral drugs.I am 18 years old or older.I am not on high-dose steroids or need machines to help me breathe or maintain my blood pressure.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A
- Group 2: Cohort B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Cohort A fulfilled all regulatory requirements to be authorized by the FDA?
"Cohort A's safety was assessed as a 2, due to the fact that this is a Phase-2 trial and no efficacy data has been collected yet."
Answered by AI
Is there still capacity for individuals to volunteer in this research endeavor?
"Clinicaltrials.gov data indicates that this trial is not presently enrolling patients, even though it was first listed on December 1st 2022 and the information was last updated a few weeks later. 29 similar medical trials are currently recruiting participants, however."
Answered by AI
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