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T-cell Therapy

Donor-Derived CMV-Specific T-Cells for CMV Infection

Phase 2
Recruiting
Led By Susan Prockop, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must meet the following clinical criteria to receive CMVpp65-CTL infusions: Stable blood pressure and circulation, not requiring pressor support; Evidence of adequate cardiac function as demonstrated by EKG and/or echocardiography; A life expectancy of at least 3 weeks, even if requiring artificial ventilation; There are no age restrictions.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing whether transfusions of T-cells can help treat CMV infection. T-cells are a type of white blood cell that helps protect the body from infection. In this case, the T-cells are made from the blood of donors who are immune to CMV. The T-cells are then grown and taught to attack the CMV virus in a lab.

Who is the study for?
This trial is for patients who've had a stem cell transplant and are now struggling with CMV infections or ongoing CMV viremia despite treatment. They should have stable blood pressure, adequate heart function, and at least a 3-week life expectancy. There's no age limit, but pregnant individuals or those on high steroid doses can't participate.Check my eligibility
What is being tested?
The study tests the effectiveness of transfusing T-cells that target the CMV virus into patients. These T-cells come from donors immune to CMV and are modified in a lab to fight the infection in recipients who've undergone stem cell transplants.See study design
What are the potential side effects?
Potential side effects may include reactions similar to blood transfusions, such as fever or chills. Since these T-cells are designed to attack specific viruses, there could also be risks related to immune responses like inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My blood pressure is stable without medication, my heart functions well, I am expected to live at least 3 more weeks, and my age does not disqualify me.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
complete response
Secondary outcome measures
Toxicity

Trial Design

1Treatment groups
Experimental Treatment
Group I: CMVpp65-CTL T-cellsExperimental Treatment1 Intervention
The T-cells to be infused will be selected from our bank of GMP grade CMVpp65-CTL. T-cells will be administered by bolus intravenous infusion. In this phase II trial, patients will be treated at doses of 1 x 10^6 CMVpp65-CTL/kg/dose/week for 3 weeks. Patients will be observed for the following 3 weeks. Additional 3 week courses of CMVpp65-CTL may be administered if levels of CMV DNA in blood are still detectable despite disease stabilization or improvement.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,940 Previous Clinical Trials
588,851 Total Patients Enrolled
Susan Prockop, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
6 Previous Clinical Trials
121 Total Patients Enrolled

Media Library

CMVpp65 Specific T-cells (T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02136797 — Phase 2
Cytomegalovirus Research Study Groups: CMVpp65-CTL T-cells
Cytomegalovirus Clinical Trial 2023: CMVpp65 Specific T-cells Highlights & Side Effects. Trial Name: NCT02136797 — Phase 2
CMVpp65 Specific T-cells (T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02136797 — Phase 2
~4 spots leftby Jun 2025
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