Expanded Access Protocol of ATA230 (Third-Party Donor-Derived CMV-CTLs) for the Treatment of CMV Viremia or Disease
Primary Purpose
CMV Viremia, CMV Disease
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Cytomegalovirus-specific Cytotoxic T Lymphocytes (CMV-CTLs)
Sponsored by
About this trial
This is an expanded access trial for CMV Viremia focused on measuring Cytomegalovirus, Cytomegalovirus Viremia, Cytomegalovirus Infection, CMV Infection, Hematopoietic Cell Transplant, Solid Organ Transplant, Human Immunodeficiency Virus, Cytomegalovirus Disease, Hematopoietic Stem Cell Transplant, CMV, CMV syndrome, Cytomegalovirus syndrome, CMV disease, CMV viremia, allogeneic, third-party
Eligibility Criteria
Inclusion Criteria:
A subject will be considered eligible to participate in the study if the following inclusion criteria are satisfied:
- Has a clinically documented condition associated with CMV disease (eg, interstitial pneumonia, hepatitis, encephalitis, retinitis, colitis) or microbiological evidence of CMV viremia or tissue invasion with CMV infection (as determined by viral culture or levels of CMV DNA in blood or body fluids)
The CMV disease or CMV viremia is characterized by at least one of the following:
- CMV disease is persistent or clinically progressing despite ≥ 2 weeks of antiviral therapy
- CMV viremia/disease is persistent or increasing (determined by quantitation of blood CMV DNA) despite ≥ 2 weeks of antiviral therapy
- A genetic mutation associated with antiviral drug resistance is present
- Unable to continue antiviral drugs due to drug-associated toxicity.
- No other comparable or satisfactory therapies are available for treatment of CMV
- Not eligible for any other trials supporting development of ATA230
- For subjects who received an alloHCT, the underlying disease for which the alloHCT was performed is in morphologic remission
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3× the upper limit of normal (ULN) and total bilirubin < 2.5×ULN unless caused by CMV
- Availability of appropriate ATA230 cell lot (ie, HLA partially-matched and restricted CMV-CTLs)
- Subject or subject's representative is willing and able to provide written informed consent
Exclusion Criteria:
A subject will not be eligible to participate in the study if any of the following criteria are met:
- Receiving concomitant investigational therapy (co-enrollment in a non-interventional study or a study for follow-up or sample collection only is permitted)
- Need for antimetabolite agents (eg, methotrexate), or extracorporeal photopheresis
- Antithymocyte globulin or similar anti-T cell antibody therapy ≤ 4 weeks prior to the first dose of ATA230 (on Day 1 of Cycle 1)
- Need for vasopressor or ventilator support
- Pregnancy, except when ATA230 is clearly needed
- Female of childbearing potential or male with a female partner of childbearing potential unwilling to use a highly effective method of contraception
- Inability to comply with study procedures
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03010332
Brief Title
Expanded Access Protocol of ATA230 (Third-Party Donor-Derived CMV-CTLs) for the Treatment of CMV Viremia or Disease
Official Title
An Expanded Access Protocol of ATA230 (Third-Party Donor-Derived Cytomegalovirus-Specific T Cells) for the Treatment of CMV Viremia or Disease in Subjects for Whom There Are No Other Comparable Options
Study Type
Expanded Access
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atara Biotherapeutics
4. Oversight
5. Study Description
Brief Summary
This is an expanded access protocol designed to provide access of ATA230 to subjects with cytomegalovirus (CMV) viremia or disease, who are intolerant to, or failed, standard antiviral therapy and have no comparable treatment options.
Detailed Description
ATA230 (third-party donor-derived CMV-CTLs) are cytotoxic T lymphocytes that specifically kill cells presenting CMV protein antigens.
This is an expanded access protocol designed to provide access of ATA230 to subjects with CMV viremia or disease, who are intolerant to, or failed, standard antiviral therapy and have no comparable treatment options. This study will enroll subjects regardless of the underlying susceptibility to CMV, including allogeneic hematopoietic cell transplant (alloHCT), solid organ transplant (SOT), human immunodeficiency virus (HIV), other immunocompromised states, and immune competent subjects who require therapy. Subjects must have active CMV viremia or disease for ≥ 2 weeks despite treatment with antiviral therapy or must be intolerant to antiviral therapy due to treatment-related toxicity or comorbidities such as renal insufficiency or myelosuppression.
ATA230 will be administered in cycles lasting 5 weeks (35 days). During each cycle, subjects will receive intravenous (IV) ATA230 at a dose of 1×10^6 cells/kg (with an acceptable range of 0.8-1.0×10^6 cells/kg) on Days 1, 8, and 15, followed by observation through Day 35.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CMV Viremia, CMV Disease
Keywords
Cytomegalovirus, Cytomegalovirus Viremia, Cytomegalovirus Infection, CMV Infection, Hematopoietic Cell Transplant, Solid Organ Transplant, Human Immunodeficiency Virus, Cytomegalovirus Disease, Hematopoietic Stem Cell Transplant, CMV, CMV syndrome, Cytomegalovirus syndrome, CMV disease, CMV viremia, allogeneic, third-party
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Cytomegalovirus-specific Cytotoxic T Lymphocytes (CMV-CTLs)
Other Intervention Name(s)
ATA230
Intervention Description
ATA230 (third-party donor-derived CMV-CTLs) are cytotoxic T lymphocytes that specifically kill cells presenting CMV protein antigens.
10. Eligibility
Sex
All
Eligibility Criteria
Inclusion Criteria:
A subject will be considered eligible to participate in the study if the following inclusion criteria are satisfied:
Has a clinically documented condition associated with CMV disease (eg, interstitial pneumonia, hepatitis, encephalitis, retinitis, colitis) or microbiological evidence of CMV viremia or tissue invasion with CMV infection (as determined by viral culture or levels of CMV DNA in blood or body fluids)
The CMV disease or CMV viremia is characterized by at least one of the following:
CMV disease is persistent or clinically progressing despite ≥ 2 weeks of antiviral therapy
CMV viremia/disease is persistent or increasing (determined by quantitation of blood CMV DNA) despite ≥ 2 weeks of antiviral therapy
A genetic mutation associated with antiviral drug resistance is present
Unable to continue antiviral drugs due to drug-associated toxicity.
No other comparable or satisfactory therapies are available for treatment of CMV
Not eligible for any other trials supporting development of ATA230
For subjects who received an alloHCT, the underlying disease for which the alloHCT was performed is in morphologic remission
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3× the upper limit of normal (ULN) and total bilirubin < 2.5×ULN unless caused by CMV
Availability of appropriate ATA230 cell lot (ie, HLA partially-matched and restricted CMV-CTLs)
Subject or subject's representative is willing and able to provide written informed consent
Exclusion Criteria:
A subject will not be eligible to participate in the study if any of the following criteria are met:
Receiving concomitant investigational therapy (co-enrollment in a non-interventional study or a study for follow-up or sample collection only is permitted)
Need for antimetabolite agents (eg, methotrexate), or extracorporeal photopheresis
Antithymocyte globulin or similar anti-T cell antibody therapy ≤ 4 weeks prior to the first dose of ATA230 (on Day 1 of Cycle 1)
Need for vasopressor or ventilator support
Pregnancy, except when ATA230 is clearly needed
Female of childbearing potential or male with a female partner of childbearing potential unwilling to use a highly effective method of contraception
Inability to comply with study procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Willis Navarro, MD
Organizational Affiliation
Atara Biotherapeutics
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Expanded Access Protocol of ATA230 (Third-Party Donor-Derived CMV-CTLs) for the Treatment of CMV Viremia or Disease
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