← Back to Search

Virus Therapy

CMV-Specific CTLs for CMV Infection

Phase 2

Recruiting

Led By Mitchell S Cairo, MD

Research Sponsored by New York Medical College

Eligibility Criteria Checklist

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

Must have

Donor Eligibility: Related donor available with a T-cell response to the CMV MACS® GMP PepTivator antigen(s) or third party related allogeneic donor (family donor > 1 HLA A, B, DR match to recipient) with IgG positive to CMV and/or a T-cell response to the CMV MACS® GMP PepTivator

Age: 0.1 to 79.99 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up patients will be followed for 12 weeks after each infusion

Awards & highlights

Study Summary

This trial will test whether CMV CTLs can be safely administered to children, adolescents, and young adults with CMV infection who have not responded to previous treatment.

Who is the study for?

This trial is for children, adolescents, and young adults aged 0.1 to 30.99 years with refractory CMV infection after a stem cell or organ transplant, or those with primary immunodeficiencies. Participants must have tried antiviral therapy without success or cannot tolerate it due to side effects like low white blood cell counts or kidney issues.Check my eligibility

What is being tested?

The study tests the use of virus-specific cytotoxic T-lymphocytes (CTLs) in patients who haven't responded well to standard treatments for CMV infections post-transplantation. These CTLs are developed using a special system and aim to fight off the persistent infection.See study design

What are the potential side effects?

Potential side effects may include immune reactions as the body adjusts to new T-cells, infusion-related responses such as fever or chills, and possible worsening of existing conditions like GVHD if present.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have a family donor who matches me and is CMV positive or has a T-cell response to CMV.

Select...

I am between the ages of 0 and 79.

Select...

I can do most activities by myself.

Select...

I am a woman who can have children and my pregnancy test is negative.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ patients will be followed 12 weeks after each infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~patients will be followed 12 weeks after each infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and patients will be followed 12 weeks after each infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Response to Treatment

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Trial Design

1Treatment groups

Experimental Treatment

Group I: Refractory CMVExperimental Treatment1 Intervention

Patients with refractory CMV will be given one dose of CMV specific CTLs. HLA matched donors will get Dose 2.5 × 10(4) CD3/kg recipient weight; HLA mismatched will get 0.5x10(4) CD3/kg recipient weight. Additional doses may be given for a total of 5 doses if patients do not have a response to the first dose with a reduction in viral load to normal limits.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaOTHER

708 Previous Clinical Trials

8,580,987 Total Patients Enrolled

Medical College of WisconsinOTHER

609 Previous Clinical Trials

1,162,563 Total Patients Enrolled

Indiana UniversityOTHER

980 Previous Clinical Trials

983,283 Total Patients Enrolled

Media Library

Viral Specific Cytotoxic T-Lymphocytes (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03266640 — Phase 2

$Cytomegalovirus Research Study Groups: Refractory CMV$

Cytomegalovirus Clinical Trial 2023: Viral Specific Cytotoxic T-Lymphocytes Highlights & Side Effects. Trial Name: NCT03266640 — Phase 2

Viral Specific Cytotoxic T-Lymphocytes (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03266640 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment currently in progress for this experiment?

"Affirmative. The information on clinicaltrials.gov affirms that this research study is actively seeking volunteers, having first been posted November 1st 2018 and most recently edited September 27th 2022. A total of 20 patients are needed to be recruited from 8 distinct trial sites."

Answered by AI

Are there any Canadian institutions currently conducting this research?

"There are 8 sites participating in this trial, such as Children's Hospital Los Angeles in LA, Johns Hopkins University in Baltimore and the University of California San Francisco. Additionally there are 5 other centres included."

Answered by AI

Am I eligible to become involved in this research project?

"This trial is inviting 20 individuals suffering from cytomegalovirus infections aged a month to 30 years. Notably, applicants should meet the following requirements: possess an HLA A, B, DR match with their donor of greater than 1 if they are using a third-party allogeneic donor and have IgG positive antibodies towards CMV as well as generate T-cell response when exposed to MACS® GMP PepTivator antigens."

Answered by AI

Is this research project seeking participants who are 55 years old or older?

"This trial is searching for participants over 1 Month and below 30 years of age."

Answered by AI

What is the cap on the total number of research subjects in this experiment?

"This medical experiment requires a cohort of 20 individuals that meet the criteria for inclusion. Potential participants can join from either Children's Hospital Los Angeles in California or Johns Hopkins in Maryland."

Answered by AI

Has the FDA sanctioned viral specific cytotoxic t-lymphocytes for therapeutic use?

"Our team at Power deemed viral specific cytotoxic t-lymphocytes to be a relatively safe option with a rating of 2. This is based on the Phase 2 trial evidence which indicates that while safety data exists, efficacy has yet to be ascertained."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV)

Mitchell Cairo 2018. "Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03266640.

All > Cmv