Expanded Access Protocol of ATA230 (Third-Party Donor-Derived CMV-CTLs) for the Treatment of CMV Viremia or Disease
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
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expanded_access
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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.
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2017
CompletedFirst Posted
Study publicly available on registry
January 5, 2017
CompletedApril 8, 2019
April 1, 2019
January 3, 2017
April 4, 2019
Conditions
Keywords
Interventions
ATA230 (third-party donor-derived CMV-CTLs) are cytotoxic T lymphocytes that specifically kill cells presenting CMV protein antigens.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Willis Navarro, MD
Atara Biotherapeutics
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2017
First Posted
January 5, 2017
Last Updated
April 8, 2019
Record last verified: 2019-04