Trial Outcomes & Findings for Multivirus-specific T Cells for the Treatment of Virus Infections After Stem Cell Transplant (NCT NCT02108522)
NCT ID: NCT02108522
Last Updated: 2021-07-20
Results Overview
Consented subjects will be screened for a suitable VST line to asses feasibility of finding a sufficiently matching VST line.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
82 participants
Primary outcome timeframe
within 24 hours of receiving recipient HLA information
Results posted on
2021-07-20
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Screening Period
STARTED
|
82
|
|
Screening Period
COMPLETED
|
58
|
|
Screening Period
NOT COMPLETED
|
24
|
|
Period 1: Initial Cohort
STARTED
|
50
|
|
Period 1: Initial Cohort
COMPLETED
|
28
|
|
Period 1: Initial Cohort
NOT COMPLETED
|
22
|
|
Period 2: Expansion Cohort
STARTED
|
8
|
|
Period 2: Expansion Cohort
COMPLETED
|
2
|
|
Period 2: Expansion Cohort
NOT COMPLETED
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age was not collected for patients who were screened for the study but did not receive investigational product.
Baseline characteristics by cohort
| Measure |
Multivirus Specific T Cells
n=58 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
21 Participants
n=5 Participants • Age was not collected for patients who were screened for the study but did not receive investigational product.
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants • Age was not collected for patients who were screened for the study but did not receive investigational product.
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants • Age was not collected for patients who were screened for the study but did not receive investigational product.
|
|
Age, Continuous
|
33 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants • Demographics for patients who were screened for the study but did not receive investigational product were not collected.
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants • Demographics for patients who were screened for the study but did not receive investigational product were not collected.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 24 hours of receiving recipient HLA informationPopulation: Includes all patients screened for the study
Consented subjects will be screened for a suitable VST line to asses feasibility of finding a sufficiently matching VST line.
Outcome measures
| Measure |
Multivirus Specific T Cells
n=82 Participants
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.
|
|---|---|
|
Number of Patients Where a Suitable VST Line Could be Found
|
80 Participants
|
PRIMARY outcome
Timeframe: 42 daysPopulation: Includes all patients who received at least one dose of investigational product
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.
Outcome measures
| Measure |
Multivirus Specific T Cells
n=58 Participants
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.
|
|---|---|
|
Number of Patients With Acute GvHD Grades III-IV
|
1 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Includes all patients who received at least one dose of investigational product. There were no patients with grade 5, 1 patient with grade 4, and 5 patients with grade 3 treatment related adverse experiences.
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.
Outcome measures
| Measure |
Multivirus Specific T Cells
n=58 Participants
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.
|
|---|---|
|
Number of Patients With Grades 3-5 Non-hematologic Adverse Events Related to the T Cell Product
|
6 Participants
|
SECONDARY outcome
Timeframe: 42 daysPopulation: Includes all patients who received at least one dose of investigational product
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.
Outcome measures
| Measure |
Multivirus Specific T Cells
n=58 Participants
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.
|
|---|---|
|
Number of Participants With a Viral Response at 42 Days
|
54 Participants
|
SECONDARY outcome
Timeframe: 12 monthsReconstitution 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.
Outcome measures
| Measure |
Multivirus Specific T Cells
n=55 Participants
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.
|
|---|---|
|
Number of Patients With Reconstitution of Antiviral Immunity (as Measured in Peripheral Blood)
|
28 Participants
|
SECONDARY outcome
Timeframe: Within 6 weeksPopulation: Includes only patients who had at least 1 dose of investigational product, and had cells collected for analysis within 6 weeks of infusion.
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.
Outcome measures
| Measure |
Multivirus Specific T Cells
n=16 Participants
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.
|
|---|---|
|
Persistence of VSTs (in Peripheral Blood)
|
11 Participants
|
SECONDARY outcome
Timeframe: 6 weeksPatients 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.
Outcome measures
| Measure |
Multivirus Specific T Cells
n=21 Participants
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.
|
|---|---|
|
Association Between High HLA Matching and Viral Outcomes
|
18 Participants
|
SECONDARY outcome
Timeframe: 6 weeksPatients 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.
Outcome measures
| Measure |
Multivirus Specific T Cells
n=16 Participants
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.
|
|---|---|
|
Association Between Low HLA Matching and Viral Outcomes
|
16 Participants
|
SECONDARY outcome
Timeframe: 3 monthsViral 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.
Outcome measures
| Measure |
Multivirus Specific T Cells
n=58 Participants
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.
|
|---|---|
|
Number of Patients With a Clinical Response 3 Months After the First Dose of VSTs
|
54 Participants
|
SECONDARY outcome
Timeframe: 12 monthsAll 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.
Outcome measures
| Measure |
Multivirus Specific T Cells
n=58 Participants
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.
|
|---|---|
|
Number of Patients With Non-target Viral Reactivations Within 12 Months
|
19 Participants
|
SECONDARY outcome
Timeframe: 30 daysSecondary 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.
Outcome measures
| Measure |
Multivirus Specific T Cells
n=58 Participants
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.
|
|---|---|
|
Number of Patients With Secondary Graft Failure at 30 Days
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Includes all patients that were assessed for chronic GVHD. Eight patients had chronic GVHD. All 8 patients evaluated with chronic GVHD had either preexisting or a history of acute or 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.
Outcome measures
| Measure |
Multivirus Specific T Cells
n=36 Participants
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.
|
|---|---|
|
Number of Patients With Chronic GVHD
|
8 Participants
|
Adverse Events
Multivirus Specific T Cells
Serious events: 17 serious events
Other events: 15 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Multivirus Specific T Cells
n=58 participants at risk
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.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
5.2%
3/58 • Number of events 3 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Hepatobiliary disorders
Aspartate Aminotransferase Increased
|
5.2%
3/58 • Number of events 3 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.4%
2/58 • Number of events 2 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Blood and lymphatic system disorders
Sepsis
|
1.7%
1/58 • Number of events 1 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Gastrointestinal disorders
Vomiting
|
5.2%
3/58 • Number of events 4 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
1.7%
1/58 • Number of events 1 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
General disorders
Fever
|
3.4%
2/58 • Number of events 4 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Blood and lymphatic system disorders
Anemia
|
1.7%
1/58 • Number of events 1 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Blood and lymphatic system disorders
Platelet Count Decreased
|
1.7%
1/58 • Number of events 1 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Nervous system disorders
Vertigo
|
1.7%
1/58 • Number of events 2 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Vascular disorders
Hypertension
|
1.7%
1/58 • Number of events 1 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
General disorders
Multi-organ failure
|
5.2%
3/58 • Number of events 3 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
General disorders
Nausea
|
3.4%
2/58 • Number of events 2 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Gastrointestinal disorders
Diarrhea
|
1.7%
1/58 • Number of events 1 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Infections and infestations
Influenza
|
1.7%
1/58 • Number of events 1 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Hepatobiliary disorders
Renal Failure
|
1.7%
1/58 • Number of events 1 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Infections and infestations
Coronavirus Infection
|
1.7%
1/58 • Number of events 1 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.7%
1/58 • Number of events 1 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
1/58 • Number of events 1 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Investigations
Creatinine Increased
|
3.4%
2/58 • Number of events 3 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Nervous system disorders
Dizziness
|
1.7%
1/58 • Number of events 1 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.7%
1/58 • Number of events 1 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.7%
1/58 • Number of events 1 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Renal and urinary disorders
Hematuria
|
1.7%
1/58 • Number of events 1 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.7%
1/58 • Number of events 1 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.7%
1/58 • Number of events 1 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.7%
1/58 • Number of events 1 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.7%
1/58 • Number of events 1 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.7%
1/58 • Number of events 1 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Renal and urinary disorders
Proteinuria
|
1.7%
1/58 • Number of events 1 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Renal and urinary disorders
Urinary Incontinence
|
1.7%
1/58 • Number of events 1 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
Other adverse events
| Measure |
Multivirus Specific T Cells
n=58 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Sinus tachycardia
|
5.2%
3/58 • Number of events 3 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
General disorders
Abdominal Pain
|
5.2%
3/58 • Number of events 3 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Gastrointestinal disorders
Diarrhea
|
3.4%
2/58 • Number of events 2 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Gastrointestinal disorders
Nausea
|
5.2%
3/58 • Number of events 3 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
General disorders
Fatigue
|
8.6%
5/58 • Number of events 5 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
General disorders
Pyrexia
|
3.4%
2/58 • Number of events 2 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Renal and urinary disorders
Proteinuria
|
10.3%
6/58 • Number of events 6 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.3%
6/58 • Number of events 6 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.4%
2/58 • Number of events 2 • From first injection of study drug up to 28 days after last injection of study drug
Non-hematologic adverse events, grades 3-5 (according to common terminology criteria for adverse events)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place