Cytomegalovirus InfectionsEarly Phase 1NCT02982902
T Cell Therapy of Opportunistic Cytomegalovirus Infection
A Early Phase 1 study testing CMV specific adoptive t-cells in people with Cytomegalovirus Infections and Hematopoietic Stem Cell Transplant, run by Mari Dallas at 1 site in United States.
Trial summary
The purpose of this study is to determine if a specific type of cell-based immunotherapy, using T-cells from a donor that are specific against cytomegalovirus (CMV) is feasible to treat infections by CMV. Read more about this study
- Who is it for?
- Ages 3 months and older
- Conditions the study is for
- Cytomegalovirus Infections, Hematopoietic Stem Cell Transplant, Opportunistic Infections
- What is being tested?
- CMV specific adoptive t-cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2020to Aug 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 3 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have received allogeneic hematopoietic stem cell transplant and be greater than 30 days post-transplant at the time of registration
- Patients must have documented opportunistic CMV infection, or reactivation; the criteria include (both of the following criteria must be met)
- Patients may have asymptomatic viremia (>1000 copies/ml) OR presence of symptoms secondary to CMV infection, AND
- Patients must have ONE OF THE NEXT FOUR CRITERIA:
- Absence of an improvement of viral load after ≥ 14 days of antiviral therapy with ganciclovir, valganciclovir or foscarnet (decrease by at least 1 log, i.e. 10-fold) or
- New, persistent and/or worsening CMV-related symptoms, signs and/or markers of end organ compromise while on antiviral therapy with ganciclovir, valganciclovir or foscarnet, or
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- Have contraindications or experience adverse effects of antiviral therapy with ganciclovir, valganciclovir or foscarnet.
- Second recurrence of CMV viremia, CMV-related symptoms, signs and/or markers of end organ compromise.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3
- Women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) 4 weeks prior to study entry, for the duration of study participation and for 3 months after completing treatment.
- Subjects must have the ability to understand and the willingness to sign a written informed consent document, or assent document.
Who cannot join
- Pregnant or breastfeeding women are excluded from this study.
- Patients with opportunistic viral infections other than CMV.
- Patients with active, grade 2-4, acute graft vs. host disease (GVHD), chronic GVHD or any condition requiring high doses of glucocorticosteroid (>0.5 mg/kg/day prednisone or its equivalent) as treatment
- Treatment with antithymocyte globulin within 28 days of planned infusion of virus - specific, antigen selected T cells.
- Treatment with virus - specific T cells within 6 weeks (42 days) of planned infusion.
- Donor eligibility
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- Related donor of T cells must be at least partially HLA compatible, matching with recipient in at least 3/6 HLA loci (HLA-A, HLA-B, and HLA-DRB1 loci will be considered for this).
- Must have evidence of a serologic response (i.e. be seropositive) against CMV.
- Age ≥ 18 years
- Must meet the criteria for donor selection defined in the Standard Operating Procedures of University Hospitals Seidman Cancer Center Stem Cell Transplant Program
- Must be capable of undergoing a single standard 2 blood volume leukapheresis or donation of one unit of whole blood
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
Mari H Dallas, MD, 1-800-641-2422, CTUReferral@UHhospitals.org
Mari H Dallas, MD
About this study
Official title: Antigen Specific Adoptive T Cell Therapy for Opportunistic Cytomegalovirus Infection Occurring After Stem Cell Transplant
The purpose of this study is to determine if a specific type of cell-based immunotherapy, using T-cells from a donor that are specific against cytomegalovirus (CMV) is feasible to treat infections by CMV.
Adoptive T-cell therapy is an investigational (experimental) therapy that works by using the blood of a donor and selecting the T-cells that can respond against a specific infectious entity. These selected T-cells are then infused to the patient, to try to give the immune system the ability to fight the infection. Adoptive T-cell therapy is experimental because it is not approved by the Food and Drug Administration (FDA).
Read the detailed description
The primary objective of this study is to determine the feasibility of the treatment of opportunistic cytomegalovirus (CMV) infections after hematopoietic stem cell transplant (HSCT) with virus-specific, antigen-selected T-cells, selected using the CliniMACS prodigy system.
Secondary Objective(s)
- To describe the safety profile of the infusion of CMV- specific, antigen selected T-cells.
- To describe the toxicities related to infusion of CMV- specific, antigen selected T-cells.
- To describe the rate of eradication of opportunistic CMV infections after HSCT and and treatment with CMV-specific, antigen-selected T-cells using the CliniMACS Prodigy System.
This feasibility study will include a single treatment cohort.
- Being tested
- CMV specific adoptive t-cells
- Keywords
- Immunotherapy, T-Cell Therapy, Lymphoproliferative Disorder
- Medical subject headings
- Cytomegalovirus Infections, Opportunistic Infections, Lymphoproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMV specific adoptive t-cellsBiological
Also called immunotherapy
It is expected that the cell dose will be in the range of 10^3 - 10^5 virus - specific, antigen selected T cells per kg of recipient weight.
| Study group | Role | What they receive |
|---|---|---|
| CMV specific adoptive t-cells | Experimental | This study involves a one-time infusion of the experimental CMV specific adoptive t-cells. After this infusion, patients will be followed for 4 weeks. Receives: Biological: CMV specific adoptive t-cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
To determine the feasibility of the intervention, the study will record the incidence of adverse events, including graft versus host disease and other complications will be evaluated using binomial distribution theory and their 95% confidence intervals (CIs) will be also estimated using Wilson's method
Measured: Up to 100 days after transplant
Secondary outcomes (2)
Eradication rate of opportunistic CMV infections
The eradication rate will be the disappearance of opportunistic CMV infections with the use of CMV-specific, antigen-selected T cells using the CliniMACS Prodigy System over the total number CMV infections.
Measured: Up to 100 days after transplant
response rate
A response rate of 25% is considered unacceptable; and the anticipated response rate is approximately 55% for the study population using the cell therapy.
Measured: Up to 100 days after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study start27 May 2020
- Primary completionAug 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionsStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mari Dallas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mari Dallas, Case Comprehensive Cancer Center
- Investigators
- Mari H Dallas, MD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982902
- Sponsor's protocol ID
- CASE1Z16
- Status last verified
- Sep 2025
- First submitted
- 2 Dec 2016
- Last updated
- 22 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antigen Specific Adoptive T Cell Therapy for Opportunistic Cytomegalovirus Infection Occurring After Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT02982902
- Acronym / sponsor ID
- CASE1Z16
- Keywords
- Immunotherapy, T-Cell Therapy, Lymphoproliferative Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mari DallasUniversity, hospital or other
- Study start
- 27 May 2020 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 6 Dec 2016 (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.
The purpose of this study is to determine if a specific type of cell-based immunotherapy, using T-cells from a donor that are specific against cytomegalovirus (CMV) is feasible to treat infections by CMV.
Adoptive T-cell therapy is an investigational (experimental) therapy that works by using the blood of a donor and selecting the T-cells that can respond against a specific infectious entity. These selected T-cells are then infused to the patient, to try to give the immune system the ability to fight the infection. Adoptive T-cell therapy is experimental because it is not approved by the Food and Drug Administration (FDA).
Detailed description
The primary objective of this study is to determine the feasibility of the treatment of opportunistic cytomegalovirus (CMV) infections after hematopoietic stem cell transplant (HSCT) with virus-specific, antigen-selected T-cells, selected using the CliniMACS prodigy system.
Secondary Objective(s)
- To describe the safety profile of the infusion of CMV- specific, antigen selected T-cells.
- To describe the toxicities related to infusion of CMV- specific, antigen selected T-cells.
- To describe the rate of eradication of opportunistic CMV infections after HSCT and and treatment with CMV-specific, antigen-selected T-cells using the CliniMACS Prodigy System.
This feasibility study will include a single treatment cohort.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMV specific adoptive t-cells | Experimental | Biological: CMV specific adoptive t-cellsThis study involves a one-time infusion of the experimental CMV specific adoptive t-cells. After this infusion, patients will be followed for 4 weeks. |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have received allogeneic hematopoietic stem cell transplant and be greater than 30 days post-transplant at the time of registration
- Patients must have documented opportunistic CMV infection, or reactivation; the criteria include (both of the following criteria must be met)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3
- Women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) 4 weeks prior to study entry, for the duration of study participation and for 3 months after completing treatment.
- Subjects must have the ability to understand and the willingness to sign a written informed consent document, or assent document.
Key exclusion criteria (11 listed)
- Pregnant or breastfeeding women are excluded from this study.
- Patients with opportunistic viral infections other than CMV.
- Patients with active, grade 2-4, acute graft vs. host disease (GVHD), chronic GVHD or any condition requiring high doses of glucocorticosteroid (>0.5 mg/kg/day prednisone or its equivalent) as treatment
- Treatment with antithymocyte globulin within 28 days of planned infusion of virus - specific, antigen selected T cells.
- Treatment with virus - specific T cells within 6 weeks (42 days) of planned infusion.
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 |
|---|---|---|
| CMV specific adoptive t-cellsAlso: immunotherapyIt is expected that the cell dose will be in the range of 10^3 - 10^5 virus - specific, antigen selected T cells per kg of recipient weight. | Biological | CMV specific adoptive t-cells |
Primary outcome
Incidence of adverse events
Time frame: Up to 100 days after transplant
To determine the feasibility of the intervention, the study will record the incidence of adverse events, including graft versus host disease and other complications will be evaluated using binomial distribution theory and their 95% confidence intervals (CIs) will be also estimated using Wilson's method
2 secondary outcomes
Eradication rate of opportunistic CMV infections
Time frame: Up to 100 days after transplant
response rate
Time frame: Up to 100 days after transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Mari H Dallas, MD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CMV specific adoptive t-cells in people with Cytomegalovirus Infections and Hematopoietic Stem Cell Transplant, run by Mari Dallas at 1 site in United States.
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 11 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mari H Dallas, MD (1-800-641-2422, CTUReferral@UHhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Up to 100 days after transplant). It is what the study was designed to measure, not a finding.
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 22 Oct 2025.