AzTrials
AzTrials

CMV InfectionPhase 2NCT02136797

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

A Phase 2 study testing CMVpp65 Specific T-cells in people with CMV Infection and Persistent CMV Viremia, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to see how well transfusions of T-cells work in treating CMV. Tcells are a type of white blood cell that helps protect the body from infection. A transfusion is the process by which blood from one person is transferred to the blood of another. Read more about this study

Who is it for?
Any age
Conditions the study is for
CMV Infection, Persistent CMV Viremia
What is being tested?
CMVpp65 Specific T-cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
1 siteUnited States
Study dates
8 May 2014to 8 Feb 2024
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Each patient must satisfy at least one of the following criteria:
  • The patient must have a clinically documented condition associated with CMV (e.g. interstitial pneumonia, hepatitis, retinitis, colitis) Or
  • The patient must have microbiological evidence of CMV viremia or tissue invasion as attested by viral culture, or detection of levels of CMV DNA in the blood or body fluids consistent with CMV infection.
  • Patient must also satisfy at least one of the following criteria:
  • The patient's CMV infection is clinically progressing or CMV viremia is persistent or increasing (as evidenced by quantitation of CMV DNA in the blood) despite two weeks induction therapy with antiviral drugs.
  • Or
Show all 18Show fewer
  • The patient has developed CMV viremia as attested by viral culture, or detection of levels of CMV DNA in blood or body fluids while receiving prophylactic doses of antiviral drugs to prevent CMV infection post transplant.
  • Or
  • The patient is unable to sustain treatment with antiviral drugs due to drug associated toxicities (e.g. myelosuppression [ANC< 1000μl/ml without GCSF support] or nephrotoxicity [corrected creatinine clearance ≤ 60 ml/min/1.73 m^2 or serum creatinine > 2 mg/dl]) CMV infections are life threatening, and may involve multiple organ systems such as the lungs, liver, gastrointestinal tract, hematopoietic and central nervous systems. Antiviral drugs used for treatment may also compromise renal and hematopoietic function. Therefore, dysfunctions of these organs will not affect eligibility for this protocol.
  • 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
  • Patient must also satisfy at least one of the following criteria:
  • The patient's HCT donor has not been previously infected by or sensitized to CMV (e.g. a cord blood transplant or a marrow or PBSC transplant from a seronegative donor).
  • The patient's HCT donor, if seropositive, is either not available or not willing to provide leukocytes for generation of CMV-specific T-cells.
  • There are CMVpp65-specific T-cells available in appropriate doses in the MSKCC Adoptive Immune T-cell Therapy Bank that are matched with the patient for 1 HLA allele and that exhibit CMVpp65-specific cytotoxic activity that is restricted by an HLA allele shared by the patient

Who cannot join

  • Patients requiring high doses of glucocorticosteroids (≥ 0.3 mg/kg prednisone or its equivalent)
  • Patients who are moribund
  • Patients with other conditions not related to CMV infection (e.g. uncontrolled bacterial sepsis or invasive fungal infection) which are also life-threatening and which would preclude evaluation of the effects of a T-cell infusion.
  • Patients who are pregnant

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Phase II 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

The purpose of this study is to see how well transfusions of T-cells work in treating CMV. Tcells are a type of white blood cell that helps protect the body from infection. A transfusion is the process by which blood from one person is transferred to the blood of another. 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.

Being tested
CMVpp65 Specific T-cells
Keywords
CMVpp65 Specific T-cells, Allogeneic Hematopoietic Stem Cell Transplantation, 14-070
Medical subject headings
Cytomegalovirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CMVpp65 Specific T-cellsBiological

Study groups in NCT02136797
Study groupRoleWhat they receive
CMVpp65-CTL T-cellsExperimentalThe 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.
Receives: Biological: CMVpp65 Specific T-cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Response

    defined as the clearance of the CMV infection 3-7 weeks following completion of the last cycle of CMV CTLs.

    Measured: 2 years

Secondary outcomes (1)

  1. Number of Participants With SAE's Possibly Related to Study Treatment

    Will be capturing and tracking Grade 3-5 toxicities which occur within 30 days following an infusion of CMVpp65-specific. For the evaluation of toxicities, the NCI Standard Toxicity Scale 4.0 will be employed.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2014 (estimated)
  2. Study start8 May 2014
  3. Primary completion8 Feb 2024
  4. Study completion8 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02136797
Sponsor's protocol ID
14-070
Status last verified
Jul 2024
First submitted
9 May 2014
Last updated
17 Oct 2024
FDA-regulated drug
Yes
FDA-regulated device
No
Expanded access
Available

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in