Trial Outcomes & Findings for Safety Trial of NK DLI From 6/6 HLA Matched Family Member Following Nonmyeloablative ASCT (NCT NCT00586690)
NCT ID: NCT00586690
Last Updated: 2017-02-08
Results Overview
Evaluate the toxicity post-infusion including mortality, occurrence of acute graft versus host disease (GVHD) and other severe toxicity until a minimum of 8 weeks following the last infusion, then at least monthly for 3 additional months. Unacceptable toxicity was defined as grade ≥ III aGVHD of the gut or liver or Grade 4 aGVHD of the skin lasting \> 7 days; other Grade 4 toxicity from the procedure in the major organs that lasted \> 5 days; or treatment-related mortality (TRM). Though these infusions are provided early following transplantation and severe toxicity could still have occurred due to the primary transplant procedure, for this study any aGVHD or other toxicities occurring after the first day of infusion of the natural killer (NK) cell enriched Donor Lymphocyte Infusions (DLIs) is considered here as study related.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
47 participants
Primary outcome timeframe
5 months
Results posted on
2017-02-08
Participant Flow
Twenty five participants were recruited through the Adult Bone Marrow Transplant Program at Duke University Medical Center. Recruitment began in May, 2005 and ended in April, 2010. Patients who met the eligibility criteria were approached about the study and informed consent was conducted for those who agreed.
Prior to initiating therapy, donors and subjects will have complete history, physical exam, routine laboratory tests, and/or radiographic tests. Recipients may have Bone marrow aspirate/biopsy repeated to check for prior abnormalities. If disease progression present, patient didn't continue with treatment.
Participant milestones
| Measure |
NK Cell Infusion
NK Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion.
|
Donor Apheresis
Leukapheresis was repeated daily up to 3 days until the target dose of cells was reached (preferably without donor receiving growth factors). When possible, cells were transfused immediately after collection and processing. If collections occurred during initial mobilization at the time of stem cell transplant, the donor was off growth factor for \>24 hours. These collections, which are extra cells collected from the donor following initial collections for transplant were sufficient for the natural killer cells used in the trial. The cells were NK selected using a CD56 antibody (CliniMACS CD56 Reagent), CliniMACSplus instrument and CliniMACS tubing set provided by Miltenyi Biotec using the company protocol (Miltenyi Biotec Inc, Auburn, California). Pre and post processing cell count, viability, Hematopoietic Progenitor Cell Assay (HPCA) and flow analysis were done.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
22
|
|
Overall Study
COMPLETED
|
5
|
22
|
|
Overall Study
NOT COMPLETED
|
16
|
0
|
Reasons for withdrawal
| Measure |
NK Cell Infusion
NK Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion.
|
Donor Apheresis
Leukapheresis was repeated daily up to 3 days until the target dose of cells was reached (preferably without donor receiving growth factors). When possible, cells were transfused immediately after collection and processing. If collections occurred during initial mobilization at the time of stem cell transplant, the donor was off growth factor for \>24 hours. These collections, which are extra cells collected from the donor following initial collections for transplant were sufficient for the natural killer cells used in the trial. The cells were NK selected using a CD56 antibody (CliniMACS CD56 Reagent), CliniMACSplus instrument and CliniMACS tubing set provided by Miltenyi Biotec using the company protocol (Miltenyi Biotec Inc, Auburn, California). Pre and post processing cell count, viability, Hematopoietic Progenitor Cell Assay (HPCA) and flow analysis were done.
|
|---|---|---|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Disease Progression
|
10
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
|
Overall Study
Lab can't accommodate
|
1
|
0
|
Baseline Characteristics
Safety Trial of NK DLI From 6/6 HLA Matched Family Member Following Nonmyeloablative ASCT
Baseline characteristics by cohort
| Measure |
NK Cell Infusion
n=25 Participants
Natural Killer (NK) Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
|
Donor Apheresis
n=22 Participants
Apheresis repeated daily up to 3 days until target dose of cells reached (preferably without donor receiving growth factors). Cells were transfused immediately after collection and processing. If collections occurred during initial mobilization at the time of stem cell transplant, the donor was off growth factor for \>24 hours. These extra cell collections from the donor were sufficient for the natural killer cells used in the trial. The cells were NK selected using a CD56 antibody (CliniMACS CD56 Reagent), CliniMACSplus instrument and CliniMACS tubing set provided by Miltenyi Biotec using the company protocol (Miltenyi Biotec Inc, Auburn, California). Pre and post processing cell count, viability, Hematopoietic Progenitor Cell Assay (HPCA) and flow analysis were done.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
47 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=93 Participants
|
22 participants
n=4 Participants
|
47 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 5 monthsPopulation: Participants who completed cell infusion.
Evaluate the toxicity post-infusion including mortality, occurrence of acute graft versus host disease (GVHD) and other severe toxicity until a minimum of 8 weeks following the last infusion, then at least monthly for 3 additional months. Unacceptable toxicity was defined as grade ≥ III aGVHD of the gut or liver or Grade 4 aGVHD of the skin lasting \> 7 days; other Grade 4 toxicity from the procedure in the major organs that lasted \> 5 days; or treatment-related mortality (TRM). Though these infusions are provided early following transplantation and severe toxicity could still have occurred due to the primary transplant procedure, for this study any aGVHD or other toxicities occurring after the first day of infusion of the natural killer (NK) cell enriched Donor Lymphocyte Infusions (DLIs) is considered here as study related.
Outcome measures
| Measure |
NK Cell Infusion
n=21 Participants
Natural Killer (NK) Cell infusion using CD56 monoclonal antibody:
The cells from leukapheresis will be NK cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
|
|---|---|
|
Toxicity
Death
|
1 participants
|
|
Toxicity
GvHD
|
8 participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Participants who completed cell infusion.
Evaluate efficacy of natural killer (NK) cell infusions in terms of progression free survival (PFS) in number of months without disease progression.
Outcome measures
| Measure |
NK Cell Infusion
n=21 Participants
Natural Killer (NK) Cell infusion using CD56 monoclonal antibody:
The cells from leukapheresis will be NK cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
|
|---|---|
|
Efficacy - Progression Free Survival
|
12 months
Interval 3.0 to 33.0
|
SECONDARY outcome
Timeframe: 8 yearsPopulation: Participants who completed infusion. 9 patients were still alive at the time of this analysis.
Evaluate efficacy of natural killer (NK) cell infusions in terms of overall survival (OS).
Outcome measures
| Measure |
NK Cell Infusion
n=21 Participants
Natural Killer (NK) Cell infusion using CD56 monoclonal antibody:
The cells from leukapheresis will be NK cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
|
|---|---|
|
Efficacy - Overall Survival
|
31 months alive post-infusion
Interval 2.0 to 92.0
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Participants who completed cell infusion.
Evaluate efficacy of natural killer (NK) cell infusions in terms of number of patients with disease progression.
Outcome measures
| Measure |
NK Cell Infusion
n=21 Participants
Natural Killer (NK) Cell infusion using CD56 monoclonal antibody:
The cells from leukapheresis will be NK cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
|
|---|---|
|
Efficacy - Disease Progression
|
10 participants
|
Adverse Events
NK Cell Infusion
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NK Cell Infusion
n=21 participants at risk
Natural Killer (NK) Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Skin GVHD
|
4.8%
1/21 • Number of events 1 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Blood and lymphatic system disorders
Hemorrhage / Bleeding
|
4.8%
1/21 • Number of events 1 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Cardiac disorders
Cardiac Left Ventricular Function
|
4.8%
1/21 • Number of events 1 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
9.5%
2/21 • Number of events 2 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.8%
1/21 • Number of events 1 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.8%
1/21 • Number of events 1 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.8%
1/21 • Number of events 1 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
Other adverse events
| Measure |
NK Cell Infusion
n=21 participants at risk
Natural Killer (NK) Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.5%
2/21 • Number of events 3 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
4.8%
1/21 • Number of events 1 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Blood and lymphatic system disorders
Hemolytic anemia
|
9.5%
2/21 • Number of events 2 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Gastrointestinal disorders
Anorexia
|
4.8%
1/21 • Number of events 1 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Gastrointestinal disorders
Ascites
|
4.8%
1/21 • Number of events 1 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Gastrointestinal disorders
Diarrhea
|
4.8%
1/21 • Number of events 3 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Gastrointestinal disorders
Gastritis
|
9.5%
2/21 • Number of events 2 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
3/21 • Number of events 3 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Infections and infestations
Febrile Neutropenia
|
9.5%
2/21 • Number of events 2 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Infections and infestations
Infection - NOS
|
4.8%
1/21 • Number of events 1 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Infections and infestations
Infection with grade 3 or 4 neutrophils
|
28.6%
6/21 • Number of events 7 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Infections and infestations
Infection - normal ANC - grade 1 or 2 neutrophils
|
23.8%
5/21 • Number of events 7 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Infections and infestations
Infection without Febrile Neutropenia
|
4.8%
1/21 • Number of events 1 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.8%
1/21 • Number of events 2 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.8%
1/21 • Number of events 1 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Metabolism and nutrition disorders
Acute Interstitial Nephritis
|
4.8%
1/21 • Number of events 2 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Metabolism and nutrition disorders
Creatinine
|
4.8%
1/21 • Number of events 1 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Nervous system disorders
Memory impairment
|
4.8%
1/21 • Number of events 1 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
4.8%
1/21 • Number of events 1 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Skin and subcutaneous tissue disorders
Basal Cell Skin Cancer
|
4.8%
1/21 • Number of events 1 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
General disorders
Fever
|
4.8%
1/21 • Number of events 1 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.8%
1/21 • Number of events 1 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Nervous system disorders
Syncope
|
9.5%
2/21 • Number of events 2 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.8%
1/21 • Number of events 1 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.8%
1/21 • Number of events 1 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Renal and urinary disorders
Cystitis
|
4.8%
1/21 • Number of events 1 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Renal and urinary disorders
Protenuria
|
4.8%
1/21 • Number of events 1 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
4.8%
1/21 • Number of events 1 • Each patient will be followed for toxicity until 8 weeks post-infusion or 5 months after the last natural killer cell infusion (NKI), whichever comes first. All adverse events will be recorded from the 1st day of infusion until the subject is off study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place