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Cell Therapy

CMV-Specific CTLs for CMV Infection Post-Transplant

Q: What is the total enrollment figure for this clinical experiment?

Affirmative, the clinicaltrials.gov page for this investigation indicates that it is currently enrolling participants. Initially posted on November 7th 2020 and updated most recently in April 2022, 10 test subjects must be found from 2 different clinics.

Q: Are there still spots open for enrollment in this experiment?

Affirmative. Perusal of the clinicaltrials.gov website confirms that this scientific exploration, which was first uploaded on November 7th 2020, is currently in search of participants. Specifically, 10 test subjects need to be recruited from 2 separate medical facilities.

Q: Could I potentially be approved to join this clinical trial?

Potential participants in this clinical trial must possess hematopoietic stem cells and fall within a 1 to 85 year age range. Currently, there is space for 10 candidates.

Q: Are any participants younger than 65 years of age eligible for this experiment?

Eligibility for this clinical trial is contingent upon the patient being between 1 year and 85 years of age.

Phase < 1

Recruiting

Led By Sumithira Vasu, MBBS

Research Sponsored by Sumithira Vasu

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study Summary

This trial is studying the side effects of donor white blood cells killing cancer cells in patients with cytomegalovirus that has come back after a stem cell or solid organ transplant.

Who is the study for?

This trial is for individuals who have had a stem cell or solid organ transplant and are experiencing CMV reactivation despite standard treatment. Participants must be at least 30 days post-transplant, with persistent CMV viremia, and not on high doses of steroids or T-cell depleting agents. A suitable donor must be haploidentical and CMV seropositive.Check my eligibility

What is being tested?

The trial is testing the effectiveness of allogeneic cytomegalovirus-specific cytotoxic T lymphocytes (CTLs) from donors in treating CMV infections that recur after a patient has undergone a transplant. The goal is to see if these white blood cells can target and kill the virus.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune response such as fever, fatigue, infusion-related symptoms, and possibly an increased risk of other infections due to the immunological nature of the treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Feasibility defined as identifying a suitable donor within 4 weeks and meeting minimum T cell doses in the final product

Incidence of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events 4.0

Secondary outcome measures

Antiviral activity defined as response to viral load

Clinical response to CTL infusions

Effects of cytomegalovirus (CMV) specific-CTL on viral loads assessed by weekly reverse transcriptase-polymerase chain reaction

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment (CMV-specific CTLs)Experimental Treatment1 Intervention

Participants receive allogeneic cytomegalovirus-specific cytotoxic T lymphocytes IV. Participants with persistent infection are eligible for second infusion after 28 days.

Group II: Treatment (AdV-specific CTLs)Experimental Treatment1 Intervention

Patients receive allogeneic adenovirus-specific cytotoxic T Lymphocytes IV. Participants with persistent infection are eligible for second infusion after 28 days.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Sumithira VasuLead Sponsor

5 Previous Clinical Trials

102 Total Patients Enrolled

Sumithira Vasu, MBBS4.36 ReviewsPrincipal Investigator - Ohio State University Comprehensive Cancer Center

Ohio State University Comprehensive Cancer Center

3 Previous Clinical Trials

33 Total Patients Enrolled

5Patient Review

Dr. Vasu is excellent at her job, and I know that she cares about me as a person — not just a patient.

Frequently Asked Questions

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

What is the total enrollment figure for this clinical experiment?

"Affirmative, the clinicaltrials.gov page for this investigation indicates that it is currently enrolling participants. Initially posted on November 7th 2020 and updated most recently in April 2022, 10 test subjects must be found from 2 different clinics."

Answered by AI

Are there still spots open for enrollment in this experiment?

"Affirmative. Perusal of the clinicaltrials.gov website confirms that this scientific exploration, which was first uploaded on November 7th 2020, is currently in search of participants. Specifically, 10 test subjects need to be recruited from 2 separate medical facilities."

Answered by AI

Could I potentially be approved to join this clinical trial?

"Potential participants in this clinical trial must possess hematopoietic stem cells and fall within a 1 to 85 year age range. Currently, there is space for 10 candidates."

Answered by AI