<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03798301</url>
  </required_header>
  <id_info>
    <org_study_id>UW18073</org_study_id>
    <secondary_id>2018-1278</secondary_id>
    <secondary_id>NCI-2019-00245</secondary_id>
    <secondary_id>A536755</secondary_id>
    <secondary_id>SMPH\PEDIATRICS\HEM-ONCOL</secondary_id>
    <secondary_id>Protocol Version: 7/15/2022</secondary_id>
    <nct_id>NCT03798301</nct_id>
  </id_info>
  <brief_title>Treatment of Cytomegalovirus (CMV) Infections With Viral-Specific T Cells</brief_title>
  <official_title>Treatment of CMV Infections With Viral-Specific T Cells Against CMV in Pediatric and Adult Immunocompromised Patients or Recipients of Allogeneic Stem Cell Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Wisconsin Carbone Cancer Center (UWCCC)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present trial will consist of the treatment of 20 pediatric and adult Hematopoietic Stem&#xD;
      Cell Transplantation (HSCT) recipients or immunocompromised participants diagnosed with&#xD;
      opportunistic Cytomegalovirus (CMV) infections with virus-specific, antigen-selected T-cells.&#xD;
      CMV-specific T-cells will be isolated from donor leukapheresis products using the CliniMACS®&#xD;
      Prodigy. Prior studies on transfer of CMV specific T-cells have been shown to be safe and&#xD;
      efficacious in the treatment of CMV infections.&#xD;
&#xD;
      The main trial objective is to evaluate the feasibility and safety of CMV-specific T-cell&#xD;
      transfer in adult and pediatric participants suffering from CMV infections or reactivation&#xD;
      following HSCT or due to other immunocompromised states (e.g.; primary immunodeficiency,&#xD;
      cytotoxic therapy).&#xD;
&#xD;
      Participants will be followed for one year.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 6, 2020</start_date>
  <completion_date type="Anticipated">September 2026</completion_date>
  <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>single-center, open-label, single-arm, pilot study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility: Number of Participants Who Drop-Out Before T-Cell Transfer</measure>
    <time_frame>up to 21 days from enrollement</time_frame>
    <description>The feasibility of this intervention will in part be accomplished by measuring the number of dropped out participants before T-Cell Transfer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility: Number of Days from Participant Enrollment to Administration of CMV-VST</measure>
    <time_frame>up to 21 days from enrollment</time_frame>
    <description>The feasibility of this intervention will in part be accomplished by measuring the amount of time from participant enrollment to administration of Cytomegalovirus-Viral Specific T-Cells (CMV-VST).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility: Successful production of CMV-VST from donors</measure>
    <time_frame>up to 21 weeks from enrollment</time_frame>
    <description>The feasibility of this intervention will be assessed by quantifying the number of successful productions of Cytomegalovirus-Viral Specific T-Cells (CMV-VST) on an intent to treat basis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety: Number of Subjects who experience infusion-related adverse events following CMV-VST infusion</measure>
    <time_frame>up to 4 hours after CMV-VST infusion</time_frame>
    <description>Incidence assessed by monitoring vital signs and specific adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety: Number of Subjects who experience newly occurring acute GVHD grade 1</measure>
    <time_frame>up to 12 weeks from CMV-VST infusion</time_frame>
    <description>Incidence of subjects who experience newly occurring acute GVHD grade 1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety: Number of subjects experiencing newly occurring acute GVHD grade ≥ 2 or experience aggravation of pre-existing acute GVHD</measure>
    <time_frame>up to 12 weeks from CMV-VST infusion</time_frame>
    <description>Incidence of newly occurring acute GVHD grade ≥ 2 or increase in grade of pre-existing acute GVHD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety: Number of subjects experiencing chronic GVHD</measure>
    <time_frame>up to 12 weeks from CMV-VST infusion</time_frame>
    <description>Incidence of chronic GVHD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of severe infusion-related adverse events or severe non-hematological adverse events</measure>
    <time_frame>up to 28 days from CMV-VST infusion</time_frame>
    <description>Incidence of infusion-related adverse events ≥ grade 3 and non-hematological adverse events ≥ grade 4 after CMV-VST, which are not due to pre-existing infection or original malignancy or pre-existing condition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety: Time to Occurrence of GVHD</measure>
    <time_frame>up to 12 weeks from CMV-VST infusion</time_frame>
    <description>Time to occurrence of acute GVHD of any grade or to occurrence of chronic GVHD will be evaluated using the Kaplan-Meier method to assess incidence and severity of acute or chronic GVHD from day of T-cell transfer. The first day of GVHD onset at a certain grade will be used to calculate a cumulative incidence curve for that GVHD grade, acute or chronic. Overall cumulative incidence curves will be computed along with the 95% confidence intervals until Week 12 after T-cell transfer with death considered as a competing risk.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy: Percentage of Participants with a ≥1 log decrease in CMV viral load</measure>
    <time_frame>up to 12 weeks from CMV-VST infusion</time_frame>
    <description>Evaluation of efficacy will in part be measured by percentage of participants with a ≥1 log decrease in CMV viral load at Week 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: Time to ≥1 log change in viral load</measure>
    <time_frame>up to 12 weeks from CMV-VST infusion</time_frame>
    <description>Evaluation of efficacy will in part be measured by time to ≥1 log change in viral load in days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: Number of Participants with CMV Clearance</measure>
    <time_frame>up to 12 weeks from CMV-VST infusion</time_frame>
    <description>Evaluation of efficacy will in part be measured by the number of patients with CMV clearance, defined as negative Polymerase Chain Reaction (PCR) from Day 7 to Week 12 after T-cell transfer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: Time to CMV Clearance</measure>
    <time_frame>up to 12 weeks from CMV-VST infusion</time_frame>
    <description>Evaluation of efficacy will in part be measured by the time to CMV clearance (defined as negative PCR) from Day 0 to first day of two subsequent negative CMV PCR studies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: Number of Participants with Reduction or Clearance of Clinical Symptoms</measure>
    <time_frame>up to 12 weeks from CMV-VST infusion</time_frame>
    <description>Evaluation of efficacy will in part be measured by the number of participants with reduction or clearance of clinical symptoms of underlying CMV infection from Day 7 to Week 12 after T-cell transfer as compared to Day 0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: Number of CMV Reactivations Following Initial Viral Clearance</measure>
    <time_frame>up to 52 weeks from CMV-VST infusion</time_frame>
    <description>Evaluation of efficacy will in part be measured by the number of CMV reactivations following initial viral clearance until Week 52.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: Overall Survival</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>Evaluation of efficacy will in part be measured by the overall survival. Overall survival rate (OS): time from T-cell transfer (Day 0) to death or last follow-up throughout the study from Day 1 to Week 52.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>CMV Infection</condition>
  <condition>Cytomegalovirus Infections</condition>
  <condition>CMV Viremia</condition>
  <condition>Opportunistic Infections</condition>
  <arm_group>
    <arm_group_label>Treatment Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Suspension of CMV-specific T-cells in 10 mL of 0.9% NaCl with 2% HSA. Single dose max. 25,000 T cells/kg body weight (BW) of the recipient delivered via IV bolus injection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CMV-specific T-cells</intervention_name>
    <description>Naturally occurring, allogeneic donor lymphocytes derived from a leukapheresis or a whole blood product, enriched for CMVspecific CD4+ and CD8+ T-cells</description>
    <arm_group_label>Treatment Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult or pediatric patient suffering from CMV reactivation/infections following HSCT&#xD;
             or due to other immunocompromised states (e.g.; primary immunodeficiency, cytotoxic&#xD;
             therapy).&#xD;
&#xD;
               -  CMV reactivation/viremia defined as positive (&gt;500 copies/ml) CMV qPCR and/or&#xD;
&#xD;
               -  Presence of symptoms secondary to CMV infection or evidence of invasive CMV&#xD;
                  infection (e.g. pneumonitis, colitis) AND&#xD;
&#xD;
               -  Patients must have ONE OF THE FOLLOWING CRITERIA:&#xD;
&#xD;
                    -  Absence of an improvement of viral load after ≥ 14 days of antiviral therapy&#xD;
                       with ganciclovir, valganciclovir or foscarnet (decrease by at least 1 log,&#xD;
                       i.e. 10-fold), or&#xD;
&#xD;
                    -  New, persistent and/or worsening CMV-related symptoms, signs and/or markers&#xD;
                       of end organ compromise while on antiviral therapy with ganciclovir,&#xD;
                       valganciclovir or foscarnet, or&#xD;
&#xD;
                    -  Have contraindications or experience adverse effects of antiviral therapy&#xD;
                       with ganciclovir, valganciclovir or foscarnet, or&#xD;
&#xD;
                    -  Known resistance to ganciclovir and/or foscarnet based on molecular testing.&#xD;
&#xD;
          2. Recipients of an allogeneic HSCT must be 28 days after stem cell infusion at the time&#xD;
             of T-cell transfer.&#xD;
&#xD;
          3. Written informed consent given by patient or legal representative.&#xD;
&#xD;
          4. Minimum patient age 1 month.&#xD;
&#xD;
          5. Minimum weight 7 lbs.&#xD;
&#xD;
          6. Female patients of childbearing age with negative pregnancy tests.&#xD;
&#xD;
          7. Patient Karnofsky/Lansky Performance Status &gt;30%.&#xD;
&#xD;
          8. Donor eligible based on FACT infectious screening requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient with acute GVHD &gt; grade 2 or active moderate or severe chronic GVHD at time of&#xD;
             T-cell transfer&#xD;
&#xD;
          2. Patient receiving steroids (&gt;1.0 mg/kg body weight (BW) prednisone equivalent) at the&#xD;
             time of T-cell transfer&#xD;
&#xD;
          3. Patient received allogeneic HSCT less than 28 days prior to T-cell transfer&#xD;
&#xD;
          4. Patient treated with donor lymphocyte infusion (DLI) within 28 days prior to T-cell&#xD;
             transfer&#xD;
&#xD;
          5. Patient treated with Thymoglobulin (ATG), Alemtuzumab or T-cell immunosuppressive&#xD;
             monoclonal antibodies within 28 days.&#xD;
&#xD;
          6. Patient with organ dysfunction or failure as determined by Karnofsky (patients &gt;16&#xD;
             years) or Lansky (patients ≤16 years) score ≤30% (Appendix 5)&#xD;
&#xD;
          7. Patients with CMV retinitis&#xD;
&#xD;
          8. Concomitant enrollment in another clinical trial with endpoints interfering with this&#xD;
             study&#xD;
&#xD;
          9. Any medical condition which could compromise participation in the study according to&#xD;
             the investigator's assessment&#xD;
&#xD;
         10. Known HIV infection&#xD;
&#xD;
         11. Female patient who is pregnant or breast-feeding, or adult of reproductive potential&#xD;
             not willing to use an effective method of birth control during study treatment. Note:&#xD;
             Women of childbearing potential must have a negative serum pregnancy test at study&#xD;
             entry.&#xD;
&#xD;
         12. Patients unwilling or unable to comply with the protocol or unable to give informed&#xD;
             consent.&#xD;
&#xD;
        Donor Eligibility:&#xD;
&#xD;
        The original donor will be the first choice as source of T cells. If the original donor is&#xD;
        not available for donation (such as NMDP donor, cord blood unit, or related donor not&#xD;
        available) of peripheral mononuclear cells or does not meet all donor eligibility criteria&#xD;
        (including donor selection criteria based on University of Wisconsin - Madison Standard&#xD;
        Operating Procedures for the selection of allogeneic donors), alternative related donors&#xD;
        will be selected, with preference for those who have full HLA matching in 6/6 loci over&#xD;
        those with partial HLA matching (≥ 3/6 HLA loci).&#xD;
&#xD;
          1. All donors must be ≥ 18 years old, available, CMV IgG positive, eligible and capable&#xD;
             of undergoing a single standard 2 blood volume leukapheresis. If original HSCT donor&#xD;
             is not available, CMV IgG negative or ineligible, a CMV IgG positive fully matched or&#xD;
             haploidentical family donor will be used.&#xD;
&#xD;
          2. Related donors must be at least partially HLA compatible, matching with recipient in&#xD;
             at least 3/6 HLA loci (HLA-A, HLA-B and HLA-DRB1 will be considered for this).&#xD;
&#xD;
          3. Donors must be CMV IgG seropositive.&#xD;
&#xD;
          4. Donors must show CMV T-cell activation after incubation with MACS GMP PepTivator&#xD;
             Peptide Pools of CMV pp65 before undergoing leukapheresis.&#xD;
&#xD;
          5. Donor must meet the criteria for donor selection defined in the Standard Operating&#xD;
             Procedures of the University of Wisconsin Hospitals and Clinics Stem Cell Transplant&#xD;
             Program and in FACT standards.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kenneth DeSantes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jacques Galipeau, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cancer Connect</last_name>
    <phone>800-622-8922</phone>
    <email>clinicaltrials@cancer.wisc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Wisconsin Carbone Cancer Center</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jenny Weiland</last_name>
      <phone>608-890-8070</phone>
      <email>jlweiland@pediatrics.wisc.edu</email>
    </contact>
    <investigator>
      <last_name>Kenneth DeSantes, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://cancer.wisc.edu/</url>
    <description>University of Wisconsin Carbone Cancer Center</description>
  </link>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>January 30, 2023</last_update_submitted>
  <last_update_submitted_qc>January 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Immunocompromised</keyword>
  <keyword>Allogeneic Stem Cell Transplantation</keyword>
  <keyword>Hematopoietic stem cell transplantation (HSCT)</keyword>
  <keyword>T-cell</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Cytomegalovirus Infections</mesh_term>
    <mesh_term>Opportunistic Infections</mesh_term>
    <mesh_term>Viremia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03798301
org study id: UW18073
secondary id: 2018-1278
secondary id: NCI-2019-00245
secondary id: A536755
secondary id: SMPH\PEDIATRICS\HEM-ONCOL
secondary id: Protocol Version: 7/15/2022
nct id: NCT03798301
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The present trial will consist of the treatment of 20 pediatric and adult Hematopoietic Stem
      Cell Transplantation (HSCT) recipients or immunocompromised participants diagnosed with
      opportunistic Cytomegalovirus (CMV) infections with virus-specific, antigen-selected T-cells.
      CMV-specific T-cells will be isolated from donor leukapheresis products using the CliniMACS®
      Prodigy. Prior studies on transfer of CMV specific T-cells have been shown to be safe and
      efficacious in the treatment of CMV infections.

      The main trial objective is to evaluate the feasibility and safety of CMV-specific T-cell
      transfer in adult and pediatric participants suffering from CMV infections or reactivation
      following HSCT or due to other immunocompromised states (e.g.; primary immunodeficiency,
      cytotoxic therapy).

      Participants will be followed for one year.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: single-center, open-label, single-arm, pilot study
primary purpose: Treatment
masking: None (Open Label)
measure: Feasibility: Number of Participants Who Drop-Out Before T-Cell Transfer
time frame: up to 21 days from enrollement
description: The feasibility of this intervention will in part be accomplished by measuring the number of dropped out participants before T-Cell Transfer.
measure: Feasibility: Number of Days from Participant Enrollment to Administration of CMV-VST
time frame: up to 21 days from enrollment
description: The feasibility of this intervention will in part be accomplished by measuring the amount of time from participant enrollment to administration of Cytomegalovirus-Viral Specific T-Cells (CMV-VST).
measure: Feasibility: Successful production of CMV-VST from donors
time frame: up to 21 weeks from enrollment
description: The feasibility of this intervention will be assessed by quantifying the number of successful productions of Cytomegalovirus-Viral Specific T-Cells (CMV-VST) on an intent to treat basis.
measure: Safety: Number of Subjects who experience infusion-related adverse events following CMV-VST infusion
time frame: up to 4 hours after CMV-VST infusion
description: Incidence assessed by monitoring vital signs and specific adverse events
measure: Safety: Number of Subjects who experience newly occurring acute GVHD grade 1
time frame: up to 12 weeks from CMV-VST infusion
description: Incidence of subjects who experience newly occurring acute GVHD grade 1
measure: Safety: Number of subjects experiencing newly occurring acute GVHD grade ≥ 2 or experience aggravation of pre-existing acute GVHD
time frame: up to 12 weeks from CMV-VST infusion
description: Incidence of newly occurring acute GVHD grade ≥ 2 or increase in grade of pre-existing acute GVHD
measure: Safety: Number of subjects experiencing chronic GVHD
time frame: up to 12 weeks from CMV-VST infusion
description: Incidence of chronic GVHD
measure: The number of severe infusion-related adverse events or severe non-hematological adverse events
time frame: up to 28 days from CMV-VST infusion
description: Incidence of infusion-related adverse events ≥ grade 3 and non-hematological adverse events ≥ grade 4 after CMV-VST, which are not due to pre-existing infection or original malignancy or pre-existing condition
measure: Safety: Time to Occurrence of GVHD
time frame: up to 12 weeks from CMV-VST infusion
description: Time to occurrence of acute GVHD of any grade or to occurrence of chronic GVHD will be evaluated using the Kaplan-Meier method to assess incidence and severity of acute or chronic GVHD from day of T-cell transfer. The first day of GVHD onset at a certain grade will be used to calculate a cumulative incidence curve for that GVHD grade, acute or chronic. Overall cumulative incidence curves will be computed along with the 95% confidence intervals until Week 12 after T-cell transfer with death considered as a competing risk.
measure: Efficacy: Percentage of Participants with a ≥1 log decrease in CMV viral load
time frame: up to 12 weeks from CMV-VST infusion
description: Evaluation of efficacy will in part be measured by percentage of participants with a ≥1 log decrease in CMV viral load at Week 12.
measure: Efficacy: Time to ≥1 log change in viral load
time frame: up to 12 weeks from CMV-VST infusion
description: Evaluation of efficacy will in part be measured by time to ≥1 log change in viral load in days.
measure: Efficacy: Number of Participants with CMV Clearance
time frame: up to 12 weeks from CMV-VST infusion
description: Evaluation of efficacy will in part be measured by the number of patients with CMV clearance, defined as negative Polymerase Chain Reaction (PCR) from Day 7 to Week 12 after T-cell transfer.
measure: Efficacy: Time to CMV Clearance
time frame: up to 12 weeks from CMV-VST infusion
description: Evaluation of efficacy will in part be measured by the time to CMV clearance (defined as negative PCR) from Day 0 to first day of two subsequent negative CMV PCR studies.
measure: Efficacy: Number of Participants with Reduction or Clearance of Clinical Symptoms
time frame: up to 12 weeks from CMV-VST infusion
description: Evaluation of efficacy will in part be measured by the number of participants with reduction or clearance of clinical symptoms of underlying CMV infection from Day 7 to Week 12 after T-cell transfer as compared to Day 0.
measure: Efficacy: Number of CMV Reactivations Following Initial Viral Clearance
time frame: up to 52 weeks from CMV-VST infusion
description: Evaluation of efficacy will in part be measured by the number of CMV reactivations following initial viral clearance until Week 52.
measure: Efficacy: Overall Survival
time frame: up to 52 weeks
description: Evaluation of efficacy will in part be measured by the overall survival. Overall survival rate (OS): time from T-cell transfer (Day 0) to death or last follow-up throughout the study from Day 1 to Week 52.
arm group label: Treatment Arm
arm group type: Experimental
description: Suspension of CMV-specific T-cells in 10 mL of 0.9% NaCl with 2% HSA. Single dose max. 25,000 T cells/kg body weight (BW) of the recipient delivered via IV bolus injection.
intervention type: Biological
intervention name: CMV-specific T-cells
description: Naturally occurring, allogeneic donor lymphocytes derived from a leukapheresis or a whole blood product, enriched for CMVspecific CD4+ and CD8+ T-cells
arm group label: Treatment Arm
criteria: 
gender: All
minimum age: 1 Month
maximum age: N/A
healthy volunteers: No
last name: Kenneth DeSantes, MD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
last name: Jacques Galipeau, MD
role: Study Director
affiliation: University of Wisconsin, Madison
last name: Cancer Connect
phone: 800-622-8922
email: clinicaltrials@cancer.wisc.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: https://cancer.wisc.edu/
description: University of Wisconsin Carbone Cancer Center
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Cytomegalovirus Infections
mesh term: Opportunistic Infections
mesh term: Viremia
sharing ipd: No