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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

This study is currently recruiting participants.
Verified February 2017 by Atara Biotherapeutics
Sponsor:
ClinicalTrials.gov Identifier:
NCT02136797
First Posted: May 13, 2014
Last Update Posted: March 1, 2017
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.
Collaborator:
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
Atara Biotherapeutics
  Purpose
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.

Condition Intervention Phase
CMV Infection Persistent CMV Viremia Genetic: CMVpp65 Specific T-cells Phase 2

Access to an investigational treatment associated with this study is temporarily not available outside the clinical trial.   More info ...

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Atara Biotherapeutics:

Primary Outcome Measures:
  • complete response [ Time Frame: 2 years ]
    defined as the clearance of the CMV infection 3-7 weeks following completion of the last cycle of CMV CTLs.


Secondary Outcome Measures:
  • safety [ Time Frame: 2 years ]
    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.


Estimated Enrollment: 41
Actual Study Start Date: May 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CMVpp65-CTL T-cells
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.
Genetic: CMVpp65 Specific T-cells

  Eligibility

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:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Each patient must satisfy at least one of the following criteria:

    1. The patient must have a clinically documented condition associated with CMV (e.g. interstitial pneumonia, hepatitis, retinitis, colitis) Or
    2. 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:

    1. 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

    2. 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

    3. 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

    1. Stable blood pressure and circulation, not requiring pressor support
    2. Evidence of adequate cardiac function as demonstrated by EKG and/or echocardiography.
    3. A life expectancy of at least 3 weeks, even if requiring artificial ventilation.
    4. There are no age restrictions
  • Patient must also satisfy at least one of the following criteria:

    1. 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).
    2. The patient's HCT donor, if seropositive, is either not available or not willing to provide leukocytes for generation of CMV-specific T-cells.
    3. 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

Exclusion Criteria:

  • 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
  Contacts and Locations
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): NCT02136797


Contacts
Contact: Susan Prockop, MD 212-639-6715
Contact: Aisha Hasan, MD 212-639-3267

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Susan Prockop, MD    212-639-6715      
Contact: Aisha Hasan, MD    212-639-3267      
Principal Investigator: Susan Prockop, MD         
Sponsors and Collaborators
Atara Biotherapeutics
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Susan Prockop, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Atara Biotherapeutics
ClinicalTrials.gov Identifier: NCT02136797     History of Changes
Other Study ID Numbers: 14-070
First Submitted: May 9, 2014
First Posted: May 13, 2014
Last Update Posted: March 1, 2017
Last Verified: February 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Atara Biotherapeutics:
CMVpp65 Specific T-cells
Allogeneic Hematopoietic Stem Cell Transplantation
14-070

Additional relevant MeSH terms:
Infection
Communicable Diseases
Viremia
Cytomegalovirus Infections
Virus Diseases
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Herpesviridae Infections
DNA Virus Infections