Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-24 @ 10:02 PM
NCT ID:
NCT03010332
Eligibility Criteria:
Inclusion Criteria:
A subject will be considered eligible to participate in the study if the following inclusion criteria are satisfied:
1. 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)
2. The CMV disease or CMV viremia is characterized by at least one of the following:
1. CMV disease is persistent or clinically progressing despite ≥ 2 weeks of antiviral therapy
2. CMV viremia/disease is persistent or increasing (determined by quantitation of blood CMV DNA) despite ≥ 2 weeks of antiviral therapy
3. A genetic mutation associated with antiviral drug resistance is present
4. Unable to continue antiviral drugs due to drug-associated toxicity.
3. No other comparable or satisfactory therapies are available for treatment of CMV
4. Not eligible for any other trials supporting development of ATA230
5. For subjects who received an alloHCT, the underlying disease for which the alloHCT was performed is in morphologic remission
6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 3× the upper limit of normal (ULN) and total bilirubin \< 2.5×ULN unless caused by CMV
7. Availability of appropriate ATA230 cell lot (ie, HLA partially-matched and restricted CMV-CTLs)
8. 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:
1. Receiving concomitant investigational therapy (co-enrollment in a non-interventional study or a study for follow-up or sample collection only is permitted)
2. Need for antimetabolite agents (eg, methotrexate), or extracorporeal photopheresis
3. Antithymocyte globulin or similar anti-T cell antibody therapy ≤ 4 weeks prior to the first dose of ATA230 (on Day 1 of Cycle 1)
4. Need for vasopressor or ventilator support
5. Pregnancy, except when ATA230 is clearly needed
6. Female of childbearing potential or male with a female partner of childbearing potential unwilling to use a highly effective method of contraception
7. Inability to comply with study procedures
Sex:
ALL
Study:
NCT03010332
Study Brief:
Protocol Section:
NCT03010332