Hematopoietic and Lymphoid Cell NeoplasmPhase 1NCT03425526
Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease
A Phase 1 study testing Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes in people with Hematopoietic and Lymphoid Cell Neoplasm and Immunocompromised, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase I trial studies the side effects of allogeneic adenovirus-specific cytotoxic T lymphocytes (donor T cell therapy) and to see how well they work in treating patients with a weakened immune system (immunocompromised) and adenovirus-related disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Immunocompromised
- What is being tested?
- Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2018to 1 Jan 2027
- Phase
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Immunocompromised patients.
- English and non-English speaking patients.
- Written informed consent and/or signed assent from patient, parent or guardian.
- Negative pregnancy test in female patients of childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use an effective contraceptive measure while on study.
- Patients age 1 year or older with asymptomatic adenovirus viremia defined as no symptoms of adenovirus disease and EITHER two positive and quantifiable qPCR tests taken one week apart or one single measurement with >/= 1000 copies.
- Patients age 1 year or older with criteria of probable or definitive adenoviral diseases as defined in Appendix A.
- Willingness to comply with the study protocol requirements.
Who cannot join
- Patients receiving prednisone > 0.1 mg/kg/day or equivalent at time of enrollment, or who have received anti-thymocyte globulin (ATG) within 14 days or have received donor lymphocyte infusion (DLI) or Campath within 28 days of enrollment.
- Patients with other uncontrolled infections: For bacterial infections, patients must be receiving therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
- Active acute graft versus host disease (GVHD) grade >= 2.
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
M D Anderson Cancer Center
Houston, Texas, 77030
David Marin, 713-792-8750
David Marin
About this study
Official title: Administration of Off-the-Shelf, Expanded, Most Closely HLA Matched, Third Party Adenovirus Specific T Cells for Therapy of Adenovirus Related Disease in Immunocompromised Patients
This phase I trial studies the side effects of allogeneic adenovirus-specific cytotoxic T lymphocytes (donor T cell therapy) and to see how well they work in treating patients with a weakened immune system (immunocompromised) and adenovirus-related disease. Allogeneic adenovirus-specific cytotoxic T lymphocytes are made from donated blood cells grown in the laboratory and are designed to kill viruses that can cause infections in immunocompromised patients with adenovirus-related disease.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the feasibility and safety of administering most closely human leukocyte antigen (HLA)-matched adenovirus specific T cell lines generated by ex vivo expansion as therapy of asymptomatic adenovirus viremia or adenovirus-related disease in immunocompromised hosts.
SECONDARY OBJECTIVES:
- To obtain preliminary data about the efficacy of administering most closely HLA-matched adenovirus specific T cell lines generated by ex vivo expansion as therapy of adenovirus viremia or adenovirus-related disease.
II. To assess the persistence of the administered cells in the patients.
OUTLINE:
Within two weeks of enrollment, patients receive allogeneic adenovirus-specific cytotoxic T lymphocytes (CTLs) intravenously (IV) over 30 minutes. Patients may receive additional allogeneic adenovirus-specific CTL infusions at the discretion of the investigator in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 12 months.
- Being tested
- Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Adenovirus-specific Cytotoxic T LymphocytesBiological
Also called Allogeneic Adenovirus-specific CTLs
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (allogeneic adenovirus-specific CTLs) | Experimental | Within two weeks of enrollment, patients receive allogeneic adenovirus-specific CTLs IV over 30 minutes. Patients may receive additional allogeneic adenovirus-specific CTL infusions at the discretion of the investigator in the absence of disease progression or unacceptable toxicity. Receives: Biological: Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0
Safety and tolerability will be assessed by laboratory assessments, adverse events, and serious adverse events. Adverse events will be graded by the CTCAE version 4.0. Categorical measures will be summarized using frequencies and percentages while continuous variables will be summarized using means, standard deviations, medians, minimums, and maximums.
Measured: Up to 1 year
Assessment of response to allogeneic adenovirus-specific cytotoxic T lymphocytes (CTLs)
The proportion of patients experiencing response will be computed with associated 95% confidence interval (CI). The 95% exact CI for the feasibility criterion of 50% will extend from 25% to 75% for 16 patients.
Measured: Up to 1 year
Secondary outcomes (5)
Overall survival (OS)
OS will be defined from treatment start date to date of death. Patients who are still alive at end of study will be censored. OS will be estimated using the Kaplan-Meier method.
Measured: From the start of study treatment up to 1 year
Relapse-free survival (RFS)
RFS (original malignancy) will be defined from treatment start date to the date of documented disease recurrence or death. Patients who are still alive without disease progression at end of study will be censored. RFS will be estimated using the Kaplan-Meier method.
Measured: From the start of study treatment up to 1 year
Cumulative incidence of adenovirus reactivation after therapy
Cumulative incidence of adenovirus reactivation after therapy will be assessed using the competing risks method. The competing risks will include relapse and death and patients who are still alive without disease progression at end of study will be censored.
Measured: Up to 1 year
Cumulative incidence of graft versus host disease (GVHD)
Cumulative incidence of grade 2-4 GVHD, grade 3-4 GVHD, and chronic GVHD will be assessed using the competing risks method. The competing risks will include relapse and death and patients who are still alive without disease progression at end of study will be censored.
Measured: Up to 1 year
Reconstitution of anti-adenovirus immunity
The number of adenovirus specific T-cells in blood will be determined for each patient. The proportion of patients with population of cells that are specific and can be detected will be computed along with associated 95% CI.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start15 Mar 2018
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David Marin, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425526
- Sponsor's protocol ID
- 2017-0350
- Other IDs
- NCI-2018-00929, 2017-0350
- Status last verified
- Sep 2026
- First submitted
- 29 Jan 2018
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Off-the-Shelf, Expanded, Most Closely HLA Matched, Third Party Adenovirus Specific T Cells for Therapy of Adenovirus Related Disease in Immunocompromised Patients
- ClinicalTrials.gov ID
- NCT03425526
- Acronym / sponsor ID
- 2017-0350
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 7 Feb 2018 (actual)
- 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 phase I trial studies the side effects of allogeneic adenovirus-specific cytotoxic T lymphocytes (donor T cell therapy) and to see how well they work in treating patients with a weakened immune system (immunocompromised) and adenovirus-related disease. Allogeneic adenovirus-specific cytotoxic T lymphocytes are made from donated blood cells grown in the laboratory and are designed to kill viruses that can cause infections in immunocompromised patients with adenovirus-related disease.
Detailed description
PRIMARY OBJECTIVES:
- To assess the feasibility and safety of administering most closely human leukocyte antigen (HLA)-matched adenovirus specific T cell lines generated by ex vivo expansion as therapy of asymptomatic adenovirus viremia or adenovirus-related disease in immunocompromised hosts.
SECONDARY OBJECTIVES:
- To obtain preliminary data about the efficacy of administering most closely HLA-matched adenovirus specific T cell lines generated by ex vivo expansion as therapy of adenovirus viremia or adenovirus-related disease.
II. To assess the persistence of the administered cells in the patients.
OUTLINE:
Within two weeks of enrollment, patients receive allogeneic adenovirus-specific cytotoxic T lymphocytes (CTLs) intravenously (IV) over 30 minutes. Patients may receive additional allogeneic adenovirus-specific CTL infusions at the discretion of the investigator in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (allogeneic adenovirus-specific CTLs) | Experimental | Biological: Allogeneic Adenovirus-specific Cytotoxic T LymphocytesWithin two weeks of enrollment, patients receive allogeneic adenovirus-specific CTLs IV over 30 minutes. Patients may receive additional allogeneic adenovirus-specific CTL infusions at the discretion of the investigator in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Immunocompromised patients.
- English and non-English speaking patients.
- Written informed consent and/or signed assent from patient, parent or guardian.
- Negative pregnancy test in female patients of childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use an effective contraceptive measure while on study.
- Patients age 1 year or older with asymptomatic adenovirus viremia defined as no symptoms of adenovirus disease and EITHER two positive and quantifiable qPCR tests taken one week apart or one single measurement with >/= 1000 copies.
Key exclusion criteria (3 listed)
- Patients receiving prednisone > 0.1 mg/kg/day or equivalent at time of enrollment, or who have received anti-thymocyte globulin (ATG) within 14 days or have received donor lymphocyte infusion (DLI) or Campath within 28 days of enrollment.
- Patients with other uncontrolled infections: For bacterial infections, patients must be receiving therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
- Active acute graft versus host disease (GVHD) grade >= 2.
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 |
|---|---|---|
| Allogeneic Adenovirus-specific Cytotoxic T LymphocytesAlso: Allogeneic Adenovirus-specific CTLsGiven IV | Biological | Treatment (allogeneic adenovirus-specific CTLs) |
Primary outcome
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0
Time frame: Up to 1 year
Safety and tolerability will be assessed by laboratory assessments, adverse events, and serious adverse events. Adverse events will be graded by the CTCAE version 4.0. Categorical measures will be summarized using frequencies and percentages while continuous variables will be summarized using means, standard deviations, medians, minimums, and maximums.
Assessment of response to allogeneic adenovirus-specific cytotoxic T lymphocytes (CTLs)
Time frame: Up to 1 year
The proportion of patients experiencing response will be computed with associated 95% confidence interval (CI). The 95% exact CI for the feasibility criterion of 50% will extend from 25% to 75% for 16 patients.
5 secondary outcomes
Overall survival (OS)
Time frame: From the start of study treatment up to 1 year
Relapse-free survival (RFS)
Time frame: From the start of study treatment up to 1 year
Cumulative incidence of adenovirus reactivation after therapy
Time frame: Up to 1 year
Cumulative incidence of graft versus host disease (GVHD)
Time frame: Up to 1 year
Reconstitution of anti-adenovirus immunity
Time frame: Up to 1 year
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 4 Sep 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
David Marin principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes in people with Hematopoietic and Lymphoid Cell Neoplasm and Immunocompromised, run by M.D. Anderson Cancer Center 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 7 inclusion and 3 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 4 Sep 2026. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 David Marin, MD (713-792-8750, dmarin@mdanderson.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 graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0 (time frame: Up to 1 year). The study lists 2 primary outcomes in all. 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 4 Sep 2026.