ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 11 of 51 for:    Recruiting, Not yet recruiting, Available Studies | "Cytomegalovirus Infections"

T Cell Therapy of Opportunistic Cytomegalovirus Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02982902
Recruitment Status : Recruiting
First Posted : December 6, 2016
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief Summary:

The purpose of this study is to determine if a specific type of cell-based immunotherapy, using T-cells from a donor that are specific against cytomegalovirus (CMV) is feasible to treat infections by CMV.

Adoptive T-cell therapy is an investigational (experimental) therapy that works by using the blood of a donor and selecting the T-cells that can respond against a specific infectious entity. These selected T-cells are then infused to the patient, to try to give the immune system the ability to fight the infection. Adoptive T-cell therapy is experimental because it is not approved by the Food and Drug Administration (FDA).


Condition or disease Intervention/treatment Phase
Cytomegalovirus Infections Hematopoietic Stem Cell Transplant Opportunistic Infections Biological: CMV specific adoptive t-cells Early Phase 1

Detailed Description:

The primary objective of this study is to determine the feasibility of the treatment of opportunistic cytomegalovirus (CMV) infections after hematopoietic stem cell transplant (HSCT) with virus-specific, antigen-selected T-cells, selected using the CliniMACS prodigy system.

Secondary Objective(s)

  • To describe the safety profile of the infusion of CMV- specific, antigen selected T-cells.
  • To describe the toxicities related to infusion of CMV- specific, antigen selected T-cells.
  • To describe the rate of eradication of opportunistic CMV infections after HSCT and and treatment with CMV-specific, antigen-selected T-cells using the CliniMACS Prodigy System.

This feasibility study will include a single treatment cohort.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Antigen Specific Adoptive T Cell Therapy for Opportunistic Cytomegalovirus Infection Occurring After Stem Cell Transplant
Study Start Date : December 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: CMV specific adoptive t-cells
This study involves a one-time infusion of the experimental CMV specific adoptive t-cells. After this infusion, patients will be followed for 4 weeks.
Biological: CMV specific adoptive t-cells
It is expected that the cell dose will be in the range of 10^3 - 10^5 virus - specific, antigen selected T cells per kg of recipient weight.
Other Name: immunotherapy



Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Up to 100 days after transplant ]
    To determine the feasibility of the intervention, the study will record the incidence of adverse events, including graft versus host disease and other complications will be evaluated using binomial distribution theory and their 95% confidence intervals (CIs) will be also estimated using Wilson's method


Secondary Outcome Measures :
  1. Eradication rate of opportunistic CMV infections [ Time Frame: Up to 100 days after transplant ]
    The eradication rate will be the disappearance of opportunistic CMV infections with the use of CMV-specific, antigen-selected T cells using the CliniMACS Prodigy System over the total number CMV infections.

  2. response rate [ Time Frame: Up to 100 days after transplant ]
    A response rate of 25% is considered unacceptable; and the anticipated response rate is approximately 55% for the study population using the cell therapy.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have received allogeneic hematopoietic stem cell transplant and be greater than 30 days post-transplant at the time of registration
  • Patients must have documented opportunistic CMV infection, or reactivation; the criteria include (both of the following criteria must be met)

    • Patients may have asymptomatic viremia (>1000 copies/ml) OR presence of symptoms secondary to CMV infection, AND
    • Patients must have ONE OF THE NEXT FOUR CRITERIA:

      • Absence of an improvement of viral load after ≥ 14 days of antiviral therapy with ganciclovir, valganciclovir or foscarnet (decrease by at least 1 log, i.e. 10-fold) or
      • New, persistent and/or worsening CMV-related symptoms, signs and/or markers of end organ compromise while on antiviral therapy with ganciclovir, valganciclovir or foscarnet, or
      • Have contraindications or experience adverse effects of antiviral therapy with ganciclovir, valganciclovir or foscarnet.
      • Second recurrence of CMV viremia, CMV-related symptoms, signs and/or markers of end organ compromise.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3
  • Women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) 4 weeks prior to study entry, for the duration of study participation and for 3 months after completing treatment.
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document, or assent document.

Exclusion Criteria:

  • Pregnant or breastfeeding women are excluded from this study.
  • Patients with opportunistic viral infections other than CMV.
  • Patients with active, grade 2-4, acute graft vs. host disease (GVHD), chronic GVHD or any condition requiring high doses of glucocorticosteroid (>0.5 mg/kg/day prednisone or its equivalent) as treatment
  • Treatment with antithymocyte globulin within 28 days of planned infusion of virus - specific, antigen selected T cells.
  • Treatment with virus - specific T cells within 6 weeks (42 days) of planned infusion.

Donor eligibility

  • Related donor of T cells must be at least partially HLA compatible, matching with recipient in at least 3/6 HLA loci (HLA-A, HLA-B, and HLA-DRB1 loci will be considered for this).
  • Must have evidence of a serologic response (i.e. be seropositive) against CMV.
  • Age ≥ 18 years
  • Must meet the criteria for donor selection defined in the Standard Operating Procedures of University Hospitals Seidman Cancer Center Stem Cell Transplant Program
  • Must be capable of undergoing a single standard 2 blood volume leukapheresis or donation of one unit of whole blood

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02982902


Contacts
Contact: Paolo F Caimi, MD 216-844-0139 paolo.caimi@case.edu

Locations
United States, Ohio
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Paolo F. Caimi    216-844-0139    paolo.caimi@case.edu   
Principal Investigator: Paolo F. Caimi         
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Paolo F Caimi, MD University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02982902     History of Changes
Other Study ID Numbers: CASE1Z16
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Case Comprehensive Cancer Center:
Immunotherapy
T-Cell Therapy
Lymphoproliferative Disorder

Additional relevant MeSH terms:
Infection
Communicable Diseases
Cytomegalovirus Infections
Opportunistic Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Parasitic Diseases