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.
Biological: Cytomegalovirus-specific Cytotoxic T Lymphocytes (CMV-CTLs)
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Full eligibility criteria for NCT03010332
Ages eligible for Study
Genders eligible for Study
Accepts Healthy Volunteers
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
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
All locations for NCT03010332
View full eligibility
Tris trial is registered with FDA with number: NCT03010332. The sponsor of the trial is Atara Biotherapeutics and it is looking for 0 volunteers for the current phase.
Official trial 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
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