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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,934 Previous Clinical Trials

588,763 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

Frequently Asked Questions

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

Are there any open positions for participants in this research project?

"That is correct. The trial was posted on May 1st, 2014 and is currently recruiting 41 participants from a single site, as stated on clinicaltrials.gov."

Answered by AI

How many people are the most that can be in this experiment at one time?

"The listings on clinicaltrials.gov show that this trial is still recruiting patients. The original posting was on May 1st, 2014 and the most recent update was on July 1st, 2022. They are looking for 41 people to participate at 1 location."

Answered by AI

How does CMVpp65 Specific T-cells affect people's health?

"The safety of CMVpp65-specific T cells was given a score of 2. This is because, while there is data supporting safety from Phase 2 trials, efficacy has not been proven."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial of Third Party Donor Derived CMVpp65 Specific T-cells for The Treatment of CMV Infection or Persistent CMV Viremia After Allogeneic Hematopoietic Stem Cell Transplantation

2014. "Trial of Third Party Donor Derived CMVpp65 Specific T-cells for The Treatment of CMV Infection or Persistent CMV Viremia After Allogeneic Hematopoietic Stem Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02136797.

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