CMV ViremiaNCT03010332
Expanded Access Protocol of ATA230 (Third-Party Donor-Derived CMV-CTLs) for the Treatment of CMV Viremia or Disease
A study testing Cytomegalovirus-specific Cytotoxic T Lymphocytes (CMV-CTLs) in people with CMV Viremia and CMV Disease, run by Atara Biotherapeutics.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- CMV Viremia, CMV Disease
- What is being tested?
- Cytomegalovirus-specific Cytotoxic T Lymphocytes (CMV-CTLs)
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- A subject will be considered eligible to participate in the study if the following inclusion criteria are satisfied:
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- CMV Viremia, CMV Disease
- Being tested
- Cytomegalovirus-specific Cytotoxic T Lymphocytes (CMV-CTLs)
- Keywords
- Cytomegalovirus, Cytomegalovirus Viremia, Cytomegalovirus Infection, CMV Infection, Hematopoietic Cell Transplant, Solid Organ Transplant, Human Immunodeficiency Virus, Cytomegalovirus Disease, Hematopoietic Stem Cell Transplant, CMV, CMV syndrome, Cytomegalovirus syndrome, CMV disease, CMV viremia, allogeneic, third-party
- Medical subject headings
- Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytomegalovirus-specific Cytotoxic T Lymphocytes (CMV-CTLs)Biological
Also called ATA230
ATA230 (third-party donor-derived CMV-CTLs) are cytotoxic T lymphocytes that specifically kill cells presenting CMV protein antigens.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMV ViremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Atara Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Willis Navarro, MD, Study director, Atara Biotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010332
- Sponsor's protocol ID
- ATA230-EAP-201
- Status last verified
- Apr 2019
- First submitted
- 3 Jan 2017
- Last updated
- 8 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03010332
- Acronym / sponsor ID
- ATA230-EAP-201
- Conditions
- CMV Viremia, CMV Disease
- Keywords
- Cytomegalovirus, Cytomegalovirus Viremia, Cytomegalovirus Infection, CMV Infection, Hematopoietic Cell Transplant, Solid Organ Transplant, Human Immunodeficiency Virus, Cytomegalovirus Disease
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Atara BiotherapeuticsIndustry (pharma, biotech, devices)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- A subject will be considered eligible to participate in the study if the following inclusion criteria are satisfied:
- 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:
- No other comparable or satisfactory therapies are available for treatment of CMV
- Not eligible for any other trials supporting development of ATA230
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytomegalovirus-specific Cytotoxic T Lymphocytes (CMV-CTLs)Also: ATA230ATA230 (third-party donor-derived CMV-CTLs) are cytotoxic T lymphocytes that specifically kill cells presenting CMV protein antigens. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Willis Navarro, MD study director
Atara Biotherapeutics
Questions about this trial
What is this clinical trial studying?
A study testing Cytomegalovirus-specific Cytotoxic T Lymphocytes (CMV-CTLs) in people with CMV Viremia and CMV Disease, run by Atara Biotherapeutics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.