Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-03-11 @ 2:53 PM
Study NCT ID:
NCT03010332
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2019-04-08
First Post:
2017-01-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access Protocol of ATA230 (Third-Party Donor-Derived CMV-CTLs) for the Treatment of CMV Viremia or Disease
Sponsor:
Atara Biotherapeutics
Organization:
Study Overview
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
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: