CompletedNCT02108522CHARMSUpdated Jul 20, 2021Results posted

Multivirus-specific T Cells for the Treatment of Virus Infections After Stem Cell Transplant

An interventional study of Multivirus Specific T cells in Infection, sponsored by AlloVir. Completed at 2 sites in United States. Per ClinicalTrials.gov, last updated 2021-07-20.

Sponsored by AlloVir · Not applicable, Interventional, and Treatment

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase: Not applicable
Study type: Interventional
Enrollment: 82
Allocation: Not applicable
Sex: All

Study summary

Patients enrolled on this study will have received a stem cell transplant. After a transplant, while the immune system grows back the patient is at risk for infection. Some viruses can stay in the body for life and if the immune system is weakened, like after a transplant, they can cause life threatening infections.

Patients enrolled on this study will have had an infection with one or more of the following viruses - Epstein Barr virus (EBV), cytomegalovirus (CMV), BK virus, JC virus, adenovirus or HHV6 (Human Herpes Virus 6).

Investigators want to see if they can use a kind of white blood cell called T cells to treat infections of these viruses after a transplant. Investigators have observed in other studies that treatment with specially trained T cells has been successful when the cells are made from the transplant donor. However as it takes 1-2 months to make the cells, that approach is not practical when a patient already has an infection.

Investigators have now generated multivirus-specific T cells (VSTs) from the blood of healthy donors and created a bank of these cells. Investigators have previously successfully used frozen multivirus-specific T cells from healthy donors to treat virus infections after bone marrow transplant and now have improved the production method to make it safer and target more viruses.

In this study, investigators want to find out if they can use these banked VSTs to fight infections caused by the viruses mentioned above.

Read the detailed description

These VST lines have been made at Baylor College of Medicine from donors for other transplant patients or other normal donors some of whom were from the National Marrow Donor Program. All donors have been screened with the standard blood bank donor questionnaire, medical history and testing for infectious disease by a doctor who is experienced in screening transplant donors. Only donors who have cleared this process and were deemed to be eligible provided blood for VST generation.

The lines were made using a special process. To make the VSTs investigators mixed donor cells with small pieces of proteins, called peptides that come from adenovirus, CMV, EBV, BKV and HHV6. These peptides stimulate donor T cells that react against the viruses to grow and train the donor T cells to kill cells that are infected with CMV, EBV, adenovirus, BKV and HHV6.

Once the investigators made sufficient numbers of VSTs, they tested them to make sure they would target cells infected with these viruses but not normal cells. Then the cells were frozen.

For patients treated on this study, the VSTs will be thawed and injected into their intravenous line. The patient will remain in the clinic for at least one hour after the infusion. After the patient receives the cells, their transplant doctor will monitor the levels of the virus the patient is infected with in their blood. The investigators will also take blood to see how long the VSTs given to the patient last in their body.

The patient will continue to be followed by their doctors after the injection. The patient will either be seen in the clinic or will be contacted by a research nurse to follow up for this study every week for 6 weeks then at 3, 6 and 12 months. The patient may have other visits for their standard care.

The patient will also have regular blood tests done to follow their counts and the viral infection, but most of these will be done as part of their standard medical care. To learn more about the way the VSTs are working in the patient's body, up to an extra 30-40 ml (6-8 teaspoons) of blood will be taken before the infusion and then at 1, 2, 3, 4, 6 weeks and 3 months. Blood should come from the central intravenous line, and should not require extra needle sticks.

All participants on this study will be infused with the same number (dose) of cells. If after the first treatment the patient has a persistent infection, we would discuss this with him/her and allow an option to receive more treatments. These additional treatments might be with cells from the same donor or if we feel that there is another donor's whose cells might be better for the patient, we would use cells from a different donor. This second product will be administered at the same dose level 28 days after the initial infusion, and subsequent infusions should be at least 14 days apart. After each VST infusion, the patient will be monitored as described above.

Conditions studied

Infection

Browse trials for

Keywords

CMV infection
EBV infection
HHV6 virus infection
BK virus infection
Adenovirus infection
JC virus infection
allogeneic stem cell transplant
Virus Specific T cells

In context

Infections

2,094 studies on the registry are indexed under Infections; 364 are open to participants now.

This study's enrollment of 82 is below the median of 113 across 1,304 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

AlloVir is the lead sponsor of 11 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

For Initial VSTs and subsequent infusions: patients will be eligible following any type of transplant if they have CMV, adenovirus, EBV, BK virus and/or HHV6 infection/disease persistent or recurrent despite 14 days of standard therapy OR after failure of treatment after 7 days of standard therapy OR if unable to tolerate standard therapy. Patients with persistent JC virus infection will be eligible as well.

Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or peripheral blood stem cells or single or double cord blood.
Treatment of the following persistent or infections despite standard therapy;
1. CMV: Treatment of persistent or relapsed CMV disease or infection after standard therapy. For CMV infection, standard therapy is defined as antiviral therapy with ganciclovir, foscarnet or cidofovir.
  - CMV disease: defined as the demonstration of CMV by specimen from visceral sites (by culture or histology) or the detection of CMV by culture or direct fluorescent antibody stain in bronchoalveolar lavage fluid in the presence of new or changing pulmonary infiltrates or changes consistent with CMV retinitis on ophthalmologic examination.
  - CMV infection: defined as the presence of CMV positivity as detected by PCR or pp65 antigenemia or culture from ONE site such as stool or blood or urine or nasopharynx.
  - Failure of antiviral therapy: defined as a rise or a fall of less than 50% in viral load in peripheral blood or any site of disease as measured by PCR or pp65 antigenemia after 7 days of antiviral therapy.
2. Adenovirus: Treatment of persistent adenovirus infection or disease despite standard therapy. Standard therapy is defined as antiviral therapy with cidofovir or an alternative antiviral agent if patient will not tolerate cidofovir therapy because of poor renal function.
  - Adenovirus infection: defined as the presence of adenoviral positivity as detected by PCR or culture from ONE site such as stool or blood or urine or nasopharynx.
  - Adenovirus disease: defined as the presence of adenoviral positivity as detected by PCR, DFA or culture from two or more sites such as stool or blood or urine or nasopharynx.
  - Failure of therapy: defined as a rise or a fall of less than 50% in viral load in peripheral blood or any site of disease as measured by PCR or any other quantitative assay) after 7 days of antiviral therapy.
3. EBV: For treatment of persistent EBV infection despite standard therapy. For EBV infection, standard therapy is defined as rituximab given at 375mg/m2 in patients for 1-4 doses with a CD20+ve tumor.
  - EBV infection: defined as Biopsy proven lymphoma with EBV genomes detected in tumor cells by immunocytochemistry or in situ PCR,Or clinical or imaging findings consistent with EBV lymphoma and/or elevated EBV viral load in peripheral blood.
  - Failure of therapy is defined as: Increase or less than 50% response at sites of disease for EBV lymphoma OR, Increase or a fall of less than 50% in EBV viral load in peripheral blood or any site of disease after 1st dose of rituximab.
4. BK virus: Treatment of persistent BK virus infection or BK virus disease despite antiviral treatment with cidofovir or leflunomide. No clear standard treatment is defined. Cidofovir has been administered in low doses as well as high doses to HSCT patients with BK infections but no randomized trials are available proving its clinical efficacy. In small trials leflunomide had activity against BK virus, therefore we will consider this agent an acceptable alternative to cidofovir, given the absence of a clear option.
  - BK virus infection is defined as the presence of BK virus positivity as detected by PCR or culture in one site such as blood or urine.
  - BK virus disease is defined as the presence of BK virus detectable by culture or PCR in blood or urine or other body fluids and symptoms of disease including, but not limited to persistent microscopic or macroscopic hematuria or detectable BK virus in more than one site.
  - Failure of therapy is defined as a rise or a fall of less than 50% in viral load in peripheral blood or any site of disease as measured by PCR or any other quantitative assay) or worsening hematuria after 7 days of antiviral therapy.
5. HHV6: Treatment of persistent HHV6 infection or disease despite antiviral treatment with ganciclovir, cidofovir and foscarnet. No clear standard treatment is defined. Ganciclovir, cidofovir and foscarnet all have variable in vitro activity against HHV-6, and may have a role in treating HHV-6-associated disease - therefore antiviral treatment with one or more of these agents will we acceptable initial therapy.
  - HHV6 virus infection is defined as the presence of elevated HHV-6 levels as detected by PCR or positive culture in one site such as CSF or blood.
  - HHV6 disease is defined as defined as the presence of HHV6 detectable by culture or PCR in one or more sites such as blood or CSF and symptoms of disease including symptoms of HHV6 encephalitis OR detectable HHV6 by PCR or culture in more than one site.
  - Failure of therapy is defined as a rise or a fall of less than 50% in viral load in peripheral blood or any site of disease (as measured by PCR or any other quantitative assay) after 7 days of antiviral therapy.
6. JC virus: Treatment of progressive or persistent JC virus infection or disease without suitable alternative treatment option. Pepmixes specific for antigens on adenovirus, EBV, CMV, HHV6 and BK virus are used to generate our multivirus-specific VSTs. No pepmix specific for the rare JC virus is used for generation of these CTLs, however given the high homology (>90%) between JC and BK and the fact that BK virus-specific T cells targeting VP1 and Large T (as targeted in our multivirus VSTs) have been administered to treat JCV-PML, resulting in viral clearance from the cerebrospinal fluid it is likely that our VSTs are efficacious against JC virus. Given the current lack of treatment options for JC virus infection or reactivation after HSCT and the risk of progression to JML, which is almost uniformly fatal, and the apparent activity of BK virus-directed T cells against JC virus infected cells, we propose including patients with progressive or persistent JC virus on this study, unless a suitable alternative therapy is available.
  - JC virus infection is defined as the presence of elevated JC virus levels as detected by PCR or positive culture in one site such as CSF or blood.
  - JC virus disease is defined as defined as the presence of JC virus detectable by culture or PCR in one or more sites such as blood or CSF and symptoms of disease including symptoms of PML OR detectable JC virus by PCR or culture in more than one site.
Patients with multiple CMV, EBV, Adenovirus, HHV6 and BK virus infections are eligible given that each infection is persistent despite standard therapy as defined above. Patients with multiple infections with one or more reactivation and one or more controlled infection are eligible to enroll.
Clinical status at enrollment to allow tapering of to equal or less than 0.5 mg/kg/day prednisone (or equivalent).
HgB>8.0
Pulse oximetry of > 90% on room air
Available multivirus-specific VSTs
Negative pregnancy test in female patients if applicable ( who have received a reduced intensity conditioning regimen).
Written and/or signed assent line from patient, parent or guardian.

Exclusion criteria

Exclusion Criteria:

Patients receiving ATG, Campath or other T cell monoclonal antibodies within 28 days of screening for enrollment.
Patients with other uncontrolled infections. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic 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.
Patients who are less than 28 days removed from their hematopoietic stem cell transplant or who have received donor lymphocyte infusions (DLI) within 28 days.
Patients with active acute grades II-IV.
Active and uncontrolled relapse of

Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

GVHD (graft-versus-host disease)

After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 82 participants (actual)

Study arms

Experimental
Multivirus Specific T cells
Partially HLA-matched multivirus specific T cells (VSTs) will be thawed and given by intravenous injection. Patients will receive 2 x 10\^7 VSTs/m2 as a single infusion. In the rare case where insufficient banked cell product is available, a lower number of cells may be infused after discussion with the principal investigator, patient and/or guardian and the treatment team. If after the first treatment there is persistent infection, there is an option to receive more treatments. These additional treatments might be with cells from the same donor or another donor whose cells are also thought to be a good match for the patient and effective against their virus. This second product will be administered at the same dose level 28 days after the initial infusion, and subsequent infusions should be at least 14 days apart.
Biological: Multivirus Specific T cells

Interventions

BiologicalMultivirus Specific T cells

What researchers measure

Primary outcomes

Number of Patients Where a Suitable VST Line Could be Found
Consented subjects will be screened for a suitable VST line to asses feasibility of finding a sufficiently matching VST line.
Time frame: within 24 hours of receiving recipient HLA information
Number of Patients With Acute GvHD Grades III-IV
Safety of VSTs based on patients with acute GvHD grades III-IV within 42 days of the last dose of VSTs. Acute GVHD grading was performed by the consensus conference criteria (1). Grade 0 represents no acute GvHD. Grade 4 represents the most severe acute GvHD.
Time frame: 42 days
Number of Patients With Grades 3-5 Non-hematologic Adverse Events Related to the T Cell Product
Safety of VSTs based on patients with grades 3-5 non-hematologic adverse events that are at least possibly related to the T cell product within 28 days of the last VST dose by NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Grade 1 Mild; asymptomatic or mild symptoms. Grade 2 Moderate symptoms. Grade 3 Severe or medically significant but not immediately life-threatening. Grade 4 Life-threatening consequences. Grade 5 Death related to AE.
Time frame: 28 days

Secondary outcomes

Number of Participants With a Viral Response at 42 Days
Viral response is defined as follows: Complete response: Return to normal range as defined by specific assay used and clinical signs and symptoms. Partial response: Decrease in viral load of at least 50% from baseline or 50% improvement of clinical signs and symptoms.
Time frame: 42 days
Number of Patients With Reconstitution of Antiviral Immunity (as Measured in Peripheral Blood)
Reconstitution of Antiviral Immunity as detected during the study as defined by virus-specific T cells \> 10 SFC/5x10e5 PBMCs for one virus or additive within the first 6 weeks after the first infusion. As determined by interferon-gamma ELISpot assay of PBMCs after stimulation with virus-specific peptides. Assay reflects antiviral activity in peripheral blood, not necessarily in the site of viral infection. Patients could therefore have a negative result in the presence of antiviral immunity.
Time frame: 12 months
Persistence of VSTs (in Peripheral Blood)
Number of patients with circulating T cells of confirmed 3rd party origin as measured by epitope mapping and other techniques. Infused versus endogenous cells were discriminated on the basis of peptide-epitope specificity in patients with adequate PBMC numbers and available reagents.
Time frame: Within 6 weeks
Association Between High HLA Matching and Viral Outcomes
Patients with 4-8 matching alleles (high HLA match) and complete or partial viral response (Viral response is defined as follows: Complete response: Return to normal range as defined by specific assay used and clinical signs and symptoms. Partial response: Decrease in viral load of at least 50% from baseline or 50% improvement of clinical signs and symptoms). See Outcome Measure 8 for low-matching outcomes.
Time frame: 6 weeks
Association Between Low HLA Matching and Viral Outcomes
Patients with 1-3 matching alleles (low HLA match) and complete or partial viral response (Viral response is defined as follows: Complete response: Return to normal range as defined by specific assay used and clinical signs and symptoms. Partial response: Decrease in viral load of at least 50% from baseline or 50% improvement of clinical signs and symptoms.) See Outcome Measure 7 for high-matching outcomes.
Time frame: 6 weeks
Number of Patients With a Clinical Response 3 Months After the First Dose of VSTs
Viral response is defined as follows: Complete response: Return to normal range as defined by specific assay used and clinical signs and symptoms. Partial response: Decrease in viral load of at least 50% from baseline or 50% improvement of clinical signs and symptoms.
Time frame: 3 months
Number of Patients With Non-target Viral Reactivations Within 12 Months
All CMV, EBV, adenovirus, BK virus, JC virus and HHV6 infections/reactivations, other than the primary infection, occurring within 12 months of VST infusion. These viral infections could have occurred after clearance of the infused VST.
Time frame: 12 months
Number of Patients With Secondary Graft Failure at 30 Days
Secondary graft failure is defined as initial neutrophil engraftment followed by subsequent decline in the ANC to less than 500/mm\^3 for three consecutive measurements on different days, unresponsive to growth factor therapy that persists for at least 14 days in the absence of a known cause such as relapse. Population includes patients with serious adverse experiences potentially related to VSTs who did not have an alternative explanation for graft failure, such as disseminated tuberculosis, or toxicity of other therapies eg. ganciclovir.
Time frame: 30 days
Number of Patients With Chronic GVHD
Number of patients with new or worsened chronic GVHD by standard criteria. By standard criteria, overall severity of chronic GvHD could be scored as none, mild, moderate, or severe.
Time frame: 12 months

Results

Posted Jul 19, 2021

Limitations and caveats

Limited information is available regarding patients who were screened for the study but were not administered investigational product. Data are preliminary and unaudited.

Participant flow

Investigational product was administered to 58 unique patients. However, one patient was enrolled twice for two separate infections. An additional 24 patients were screened but did not receive investigational product.

Screening Period

Participant flow — Screening Period
Milestone	Multivirus Specific T Cells
Started	82
Completed	58
Not completed	24

Period 1: Initial Cohort

Participant flow — Period 1: Initial Cohort
Milestone	Multivirus Specific T Cells
Started	50
Completed	28
Not completed	22

Period 2: Expansion Cohort

Participant flow — Period 2: Expansion Cohort
Milestone	Multivirus Specific T Cells
Started	8
Completed	2
Not completed	6

Outcome measures

PrimaryNumber of Patients Where a Suitable VST Line Could be Found

Consented subjects will be screened for a suitable VST line to asses feasibility of finding a sufficiently matching VST line.

Time frame:: within 24 hours of receiving recipient HLA information
Reported as:: Count of participants · Participants

Number of Patients Where a Suitable VST Line Could be Found
Participants	Multivirus Specific T Cells
Number of Patients Where a Suitable VST Line Could be Found	80

PrimaryNumber of Patients With Acute GvHD Grades III-IV

Safety of VSTs based on patients with acute GvHD grades III-IV within 42 days of the last dose of VSTs. Acute GVHD grading was performed by the consensus conference criteria (1). Grade 0 represents no acute GvHD. Grade 4 represents the most severe acute GvHD.

Time frame:: 42 days
Reported as:: Count of participants · Participants

Number of Patients With Acute GvHD Grades III-IV
Participants	Multivirus Specific T Cells
Number of Patients With Acute GvHD Grades III-IV	1

PrimaryNumber of Patients With Grades 3-5 Non-hematologic Adverse Events Related to the T Cell Product

Safety of VSTs based on patients with grades 3-5 non-hematologic adverse events that are at least possibly related to the T cell product within 28 days of the last VST dose by NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Grade 1 Mild; asymptomatic or mild symptoms. Grade 2 Moderate symptoms. Grade 3 Severe or medically significant but not immediately life-threatening. Grade 4 Life-threatening consequences. Grade 5 Death related to AE.

Time frame:: 28 days
Reported as:: Count of participants · Participants

Number of Patients With Grades 3-5 Non-hematologic Adverse Events Related to the T Cell Product
Participants	Multivirus Specific T Cells
Number of Patients With Grades 3-5 Non-hematologic Adverse Events Related to the T Cell Product	6

SecondaryNumber of Participants With a Viral Response at 42 Days

Viral response is defined as follows: Complete response: Return to normal range as defined by specific assay used and clinical signs and symptoms. Partial response: Decrease in viral load of at least 50% from baseline or 50% improvement of clinical signs and symptoms.

Time frame:: 42 days
Reported as:: Count of participants · Participants

Number of Participants With a Viral Response at 42 Days
Participants	Multivirus Specific T Cells
Number of Participants With a Viral Response at 42 Days	54

SecondaryNumber of Patients With Reconstitution of Antiviral Immunity (as Measured in Peripheral Blood)

Reconstitution of Antiviral Immunity as detected during the study as defined by virus-specific T cells \> 10 SFC/5x10e5 PBMCs for one virus or additive within the first 6 weeks after the first infusion. As determined by interferon-gamma ELISpot assay of PBMCs after stimulation with virus-specific peptides. Assay reflects antiviral activity in peripheral blood, not necessarily in the site of viral infection. Patients could therefore have a negative result in the presence of antiviral immunity.

Time frame:: 12 months
Reported as:: Count of participants · Participants

Number of Patients With Reconstitution of Antiviral Immunity (as Measured in Peripheral Blood)
Participants	Multivirus Specific T Cells
Number of Patients With Reconstitution of Antiviral Immunity (as Measured in Peripheral Blood)	28

SecondaryPersistence of VSTs (in Peripheral Blood)

Number of patients with circulating T cells of confirmed 3rd party origin as measured by epitope mapping and other techniques. Infused versus endogenous cells were discriminated on the basis of peptide-epitope specificity in patients with adequate PBMC numbers and available reagents.

Time frame:: Within 6 weeks
Reported as:: Count of participants · Participants

Persistence of VSTs (in Peripheral Blood)
Participants	Multivirus Specific T Cells
Persistence of VSTs (in Peripheral Blood)	11

SecondaryAssociation Between High HLA Matching and Viral Outcomes

Patients with 4-8 matching alleles (high HLA match) and complete or partial viral response (Viral response is defined as follows: Complete response: Return to normal range as defined by specific assay used and clinical signs and symptoms. Partial response: Decrease in viral load of at least 50% from baseline or 50% improvement of clinical signs and symptoms). See Outcome Measure 8 for low-matching outcomes.

Time frame:: 6 weeks
Reported as:: Count of participants · Participants

Association Between High HLA Matching and Viral Outcomes
Participants	Multivirus Specific T Cells
Association Between High HLA Matching and Viral Outcomes	18

SecondaryAssociation Between Low HLA Matching and Viral Outcomes

Patients with 1-3 matching alleles (low HLA match) and complete or partial viral response (Viral response is defined as follows: Complete response: Return to normal range as defined by specific assay used and clinical signs and symptoms. Partial response: Decrease in viral load of at least 50% from baseline or 50% improvement of clinical signs and symptoms.) See Outcome Measure 7 for high-matching outcomes.

Time frame:: 6 weeks
Reported as:: Count of participants · Participants

Association Between Low HLA Matching and Viral Outcomes
Participants	Multivirus Specific T Cells
Association Between Low HLA Matching and Viral Outcomes	16

SecondaryNumber of Patients With a Clinical Response 3 Months After the First Dose of VSTs

Time frame:: 3 months
Reported as:: Count of participants · Participants

Number of Patients With a Clinical Response 3 Months After the First Dose of VSTs
Participants	Multivirus Specific T Cells
Number of Patients With a Clinical Response 3 Months After the First Dose of VSTs	54

SecondaryNumber of Patients With Non-target Viral Reactivations Within 12 Months

All CMV, EBV, adenovirus, BK virus, JC virus and HHV6 infections/reactivations, other than the primary infection, occurring within 12 months of VST infusion. These viral infections could have occurred after clearance of the infused VST.

Time frame:: 12 months
Reported as:: Count of participants · Participants

Number of Patients With Non-target Viral Reactivations Within 12 Months
Participants	Multivirus Specific T Cells
Number of Patients With Non-target Viral Reactivations Within 12 Months	19

SecondaryNumber of Patients With Secondary Graft Failure at 30 Days

Secondary graft failure is defined as initial neutrophil engraftment followed by subsequent decline in the ANC to less than 500/mm\^3 for three consecutive measurements on different days, unresponsive to growth factor therapy that persists for at least 14 days in the absence of a known cause such as relapse. Population includes patients with serious adverse experiences potentially related to VSTs who did not have an alternative explanation for graft failure, such as disseminated tuberculosis, or toxicity of other therapies eg. ganciclovir.

Time frame:: 30 days
Reported as:: Count of participants · Participants

Number of Patients With Secondary Graft Failure at 30 Days
Participants	Multivirus Specific T Cells
Number of Patients With Secondary Graft Failure at 30 Days	0

SecondaryNumber of Patients With Chronic GVHD

Number of patients with new or worsened chronic GVHD by standard criteria. By standard criteria, overall severity of chronic GvHD could be scored as none, mild, moderate, or severe.

Time frame:: 12 months
Reported as:: Count of participants · Participants

Number of Patients With Chronic GVHD
Participants	Multivirus Specific T Cells
Number of Patients With Chronic GVHD	8

Adverse events

Collected over From first injection of study drug up to 28 days after last injection of study drug. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Multivirus Specific T Cells	6/58 (10.3%)	17/58 (29.3%)	15/58 (25.9%)

Most frequent serious events

Showing 10 of 31

Most frequent serious events
Event	Multivirus Specific T Cells
Respiratory FailureRespiratory, thoracic and mediastinal disorders	3/58
Aspartate Aminotransferase IncreasedHepatobiliary disorders	3/58
VomitingGastrointestinal disorders	3/58
Multi-organ failureGeneral disorders	3/58
HypoxiaRespiratory, thoracic and mediastinal disorders	2/58
FeverGeneral disorders	2/58
NauseaGeneral disorders	2/58
Creatinine IncreasedInvestigations	2/58
SepsisBlood and lymphatic system disorders	1/58
TachypneaRespiratory, thoracic and mediastinal disorders	1/58

Most frequent other events

Most frequent other events
Event	Multivirus Specific T Cells
ProteinuriaRenal and urinary disorders	6/58
Decreased appetiteMetabolism and nutrition disorders	6/58
FatigueGeneral disorders	5/58
Sinus tachycardiaCardiac disorders	3/58
Abdominal PainGeneral disorders	3/58
NauseaGastrointestinal disorders	3/58
DiarrheaGastrointestinal disorders	2/58
PyrexiaGeneral disorders	2/58
PneumoniaRespiratory, thoracic and mediastinal disorders	2/58

Baseline characteristics

Investigational product was administered to 58 unique patients, however one patient was enrolled twice for two separate infections. An additional 24 patients were screened but did not receive investigational product.

Age, Categorical
Age, Categorical(Participants)	Multivirus Specific T Cells
<=18 years	21
Between 18 and 65 years	33
>=65 years	4

Age, Continuous
Age, Continuous(years)	Multivirus Specific T Cells
Mean	33 (2 to 73)

Sex: Female, Male
Sex: Female, Male(Participants)	Multivirus Specific T Cells
Female	28
Male	30

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Multivirus Specific T Cells
Hispanic or Latino	16
Not Hispanic or Latino	42
Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Multivirus Specific T Cells
American Indian or Alaska Native	0
Asian	3
Native Hawaiian or Other Pacific Islander	0
Black or African American	3
White	51
More than one race	0
Unknown or Not Reported	1

Region of Enrollment
Region of Enrollment(participants)	Multivirus Specific T Cells
United States	58

Study locations

2 sites

Houston Methodist Hospital
Houston, Texas 77030, United States
Texas Children's Hospital
Houston, Texas 77030, United States

References and documents

Publications

Przepiorka D, Weisdorf D, Martin P, Klingemann HG, Beatty P, Hows J, Thomas ED. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995 Jun;15(6):825-8. PubMed 7581076 ↗

Study documents

Protocol and statistical analysis plan ↗ · Aug 10, 2017

PDFs hosted by the registry, ClinicalTrials.gov.

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2014, a primary completion of Dec 2018 and a completion of Dec 2019. It does not say whether these dates are actual or estimated.

Results were first posted in Jul 2021, 2 years 7 months after primary completion. A results delay was requested in May 2019.

How these figures are worked out, and which studies are left out of them.

Registered: Apr 7, 2014
First posted: Apr 9, 2014
Start: Jun 2014
Primary completionActual: Dec 2018
CompletionActual: Dec 2019
Results delay requested: May 10, 2019
Results first posted: Jul 19, 2021
Last update: Jul 20, 2021

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jul 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02108522
Lead sponsor: AlloVir
Collaborators: Center for Cell and Gene Therapy, Baylor College of Medicine, Baylor College of Medicine, The Methodist Hospital Research Institute
Responsible party: Sponsor
First posted: Apr 9, 2014
Start date: Jun 2014
Primary completion: Dec 2018
Completion: Dec 2019
Results posted: Jul 19, 2021
Last update: Jul 20, 2021

Study contacts

Bilal Omer, MD

principal investigator · Baylor College of Medicine

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Infections →

Other studies from this sponsor

AlloVir

Start the discussion