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Clinical Trial Details — Status: No longer available

Administrative data

NCT number NCT03010332
Other study ID # ATA230-EAP-201
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information

Verified date April 2019
Source Atara Biotherapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.


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.


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Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Atara Biotherapeutics
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