Expanded Access Protocol of ATA230 (Third-Party Donor-Derived CMV-CTLs) for the Treatment of CMV Viremia or Disease
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|ClinicalTrials.gov Identifier: NCT03010332|
Expanded Access Status : Temporarily not available
First Posted : January 5, 2017
Last Update Posted : January 8, 2018
|Condition or disease||Intervention/treatment|
|CMV Viremia CMV Disease||Biological: Cytomegalovirus-specific Cytotoxic T Lymphocytes (CMV-CTLs)|
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.
|Study Type :||Expanded Access|
|See clinical trials of the intervention/treatment in this expanded access record.|
|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|
- Biological: Cytomegalovirus-specific Cytotoxic T Lymphocytes (CMV-CTLs)
ATA230 (third-party donor-derived CMV-CTLs) are cytotoxic T lymphocytes that specifically kill cells presenting CMV protein antigens.Other Name: ATA230
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03010332
|Study Director:||Tapan Maniar, MD||Atara Biotherapeutics|