Trial Outcomes & Findings for Dose Escalation Study of Cyclophosphamide in HIV-Infected Subjects on HAART Receiving SB-728-T (NCT NCT01543152)
NCT ID: NCT01543152
Last Updated: 2021-05-24
Results Overview
Number of Participants with Treatment related Adverse Events in subjects who received any portion of the SB-728-T infusion
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
26 participants
Primary outcome timeframe
28 days after the SB-728-T infusion of the last subject in each Cohort and up to 12 months
Results posted on
2021-05-24
Participant Flow
Participant milestones
| Measure |
Cohort 1 - IV Cyclophosphamide 200 mg
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells 1 day following IV cyclophosphamide 200 mg
|
Cohort 2 - IV Cyclophosphamide 0.5 g/m2
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 0.5 g/m2
|
Cohort 3 - IV Cyclophosphamide 1.0 g/m2
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.0 g/m2
|
Cohort 4 - IV Cyclophosphamide 2.0 g/m2
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 2.0 g/m2
|
Cohort 5 - IV Cyclophosphamide 1.5 g/m2
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.5 g/m2
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
11
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
4
|
11
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 - IV Cyclophosphamide 200 mg
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells 1 day following IV cyclophosphamide 200 mg
|
Cohort 2 - IV Cyclophosphamide 0.5 g/m2
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 0.5 g/m2
|
Cohort 3 - IV Cyclophosphamide 1.0 g/m2
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.0 g/m2
|
Cohort 4 - IV Cyclophosphamide 2.0 g/m2
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 2.0 g/m2
|
Cohort 5 - IV Cyclophosphamide 1.5 g/m2
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.5 g/m2
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
0
|
0
|
Baseline Characteristics
Dose Escalation Study of Cyclophosphamide in HIV-Infected Subjects on HAART Receiving SB-728-T
Baseline characteristics by cohort
| Measure |
Cohort 1 - IV Cyclophosphamide 200 mg
n=3 Participants
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells 1 day following IV cyclophosphamide 200 mg
|
Cohort 2 - IV Cyclophosphamide 0.5 g/m2
n=6 Participants
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 0.5 g/m2
|
Cohort 3 - IV Cyclophosphamide 1.0 g/m2
n=11 Participants
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.0 g/m2
|
Cohort 4 - IV Cyclophosphamide 2.0 g/m2
n=3 Participants
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 2.0 g/m2
|
Cohort 5 - IV Cyclophosphamide 1.5 g/m2
n=3 Participants
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.5 g/m2
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Age, Continuous
|
44.7 years
STANDARD_DEVIATION 8.08 • n=93 Participants
|
43.2 years
STANDARD_DEVIATION 6.11 • n=4 Participants
|
41.5 years
STANDARD_DEVIATION 12.13 • n=27 Participants
|
35.3 years
STANDARD_DEVIATION 10.21 • n=483 Participants
|
50.0 years
STANDARD_DEVIATION 1.00 • n=36 Participants
|
42.5 years
STANDARD_DEVIATION 9.70 • n=10 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
24 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
20 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 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
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
21 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 28 days after the SB-728-T infusion of the last subject in each Cohort and up to 12 monthsNumber of Participants with Treatment related Adverse Events in subjects who received any portion of the SB-728-T infusion
Outcome measures
| Measure |
Cohort 1 - IV Cyclophosphamide 200 mg
n=3 Participants
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells 1 day following IV cyclophosphamide 200 mg
|
Cohort 2 - IV Cyclophosphamide 0.5 g/m2
n=6 Participants
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 0.5 g/m2
|
Cohort 3 - IV Cyclophosphamide 1.0 g/m2
n=11 Participants
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.0 g/m2
|
Cohort 4 - IV Cyclophosphamide 2.0 g/m2
n=3 Participants
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 2.0 g/m2
|
Cohort 5 - IV Cyclophosphamide 1.5 g/m2
n=3 Participants
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.5 g/m2
|
|---|---|---|---|---|---|
|
Treatment-emergent Adverse Events
|
3 participants
|
6 participants
|
11 participants
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Up to 12 months after the last SB-728-T infusionPopulation: Safety Analysis Set
Effect of repeat doses of SB-728-T on engraftment following cyclophosphamide conditioning as measured by CCR5 Modified CD4 Cells in blood at Month 12.
Outcome measures
| Measure |
Cohort 1 - IV Cyclophosphamide 200 mg
n=3 Participants
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells 1 day following IV cyclophosphamide 200 mg
|
Cohort 2 - IV Cyclophosphamide 0.5 g/m2
n=4 Participants
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 0.5 g/m2
|
Cohort 3 - IV Cyclophosphamide 1.0 g/m2
n=10 Participants
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.0 g/m2
|
Cohort 4 - IV Cyclophosphamide 2.0 g/m2
n=3 Participants
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 2.0 g/m2
|
Cohort 5 - IV Cyclophosphamide 1.5 g/m2
n=3 Participants
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.5 g/m2
|
|---|---|---|---|---|---|
|
Effect of Escalating Doses of Cyclophosphamide on SB-728-T Engraftment as Measured by CCR5 Modified CD4 Cells in Blood.
|
0.038 cells 10^9/L
Standard Deviation 0.0409
|
0.061 cells 10^9/L
Standard Deviation 0.0447
|
0.143 cells 10^9/L
Standard Deviation 0.1055
|
0.085 cells 10^9/L
Standard Deviation 0.0197
|
0.079 cells 10^9/L
Standard Deviation 0.0155
|
SECONDARY outcome
Timeframe: Up to 12 months after the last SB-728-T infusionPopulation: Safety Analysis Set
Effect of SB-728-T on plasma HIV-1 RNA levels following HAART interruption. The unit is log copies/mL, except for the Cohort 1, the unit is " copies/mL". Cohort 1 mean and SD are 0. All 3 subjects had NO HIV-1 RNA DETECTED.
Outcome measures
| Measure |
Cohort 1 - IV Cyclophosphamide 200 mg
n=3 Participants
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells 1 day following IV cyclophosphamide 200 mg
|
Cohort 2 - IV Cyclophosphamide 0.5 g/m2
n=4 Participants
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 0.5 g/m2
|
Cohort 3 - IV Cyclophosphamide 1.0 g/m2
n=11 Participants
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.0 g/m2
|
Cohort 4 - IV Cyclophosphamide 2.0 g/m2
n=3 Participants
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 2.0 g/m2
|
Cohort 5 - IV Cyclophosphamide 1.5 g/m2
n=3 Participants
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.5 g/m2
|
|---|---|---|---|---|---|
|
Effect of SB-728-T on Plasma HIV-1 RNA Levels Following HAART Interruption
|
0 log copies/mL
Standard Deviation 0
|
0.250 log copies/mL
Standard Deviation 0.5000
|
1.537 log copies/mL
Standard Deviation 1.3955
|
0.667 log copies/mL
Standard Deviation 0.5774
|
3.442 log copies/mL
Standard Deviation 1.1545
|
SECONDARY outcome
Timeframe: Up to 12 months after the last SB-728-T infusionPopulation: Safety Analysis Set
Change from baseline to month 12 in CD4+ T-cell counts in peripheral blood after repeat treatments with SB-728-T. (i.e. month 12 value - baseline value)
Outcome measures
| Measure |
Cohort 1 - IV Cyclophosphamide 200 mg
n=3 Participants
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells 1 day following IV cyclophosphamide 200 mg
|
Cohort 2 - IV Cyclophosphamide 0.5 g/m2
n=4 Participants
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 0.5 g/m2
|
Cohort 3 - IV Cyclophosphamide 1.0 g/m2
n=10 Participants
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.0 g/m2
|
Cohort 4 - IV Cyclophosphamide 2.0 g/m2
n=3 Participants
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 2.0 g/m2
|
Cohort 5 - IV Cyclophosphamide 1.5 g/m2
n=3 Participants
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.5 g/m2
|
|---|---|---|---|---|---|
|
Change From Baseline to Month 12 in CD4+ T-cell Counts in Peripheral Blood After Repeat Treatments With SB-728-T. (i.e. Month 12 Value - Baseline Value)
|
0.064 cells 10^9/L
Standard Deviation 0.1309
|
0.149 cells 10^9/L
Standard Deviation 0.3736
|
-0.043 cells 10^9/L
Standard Deviation 0.1712
|
0.153 cells 10^9/L
Standard Deviation 0.3247
|
0.099 cells 10^9/L
Standard Deviation 0.3279
|
Adverse Events
Cohort 1 - IV Cyclophosphamide 200 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2 - IV Cyclophosphamide 0.5 g/m2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 3 - IV Cyclophosphamide 1.0 g/m2
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort 4 - IV Cyclophosphamide 2.0 g/m2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 5 - IV Cyclophosphamide 1.5 g/m2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 - IV Cyclophosphamide 200 mg
n=3 participants at risk
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells 1 day following IV cyclophosphamide 200 mg
|
Cohort 2 - IV Cyclophosphamide 0.5 g/m2
n=6 participants at risk
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 0.5 g/m2
|
Cohort 3 - IV Cyclophosphamide 1.0 g/m2
n=11 participants at risk
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.0 g/m2
|
Cohort 4 - IV Cyclophosphamide 2.0 g/m2
n=3 participants at risk
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 2.0 g/m2
|
Cohort 5 - IV Cyclophosphamide 1.5 g/m2
n=3 participants at risk
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.5 g/m2
|
|---|---|---|---|---|---|
|
Infections and infestations
Cellulitis staphylococcal
|
33.3%
1/3 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Psychiatric disorders
Substance abuse
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/11 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
Other adverse events
| Measure |
Cohort 1 - IV Cyclophosphamide 200 mg
n=3 participants at risk
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells 1 day following IV cyclophosphamide 200 mg
|
Cohort 2 - IV Cyclophosphamide 0.5 g/m2
n=6 participants at risk
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 0.5 g/m2
|
Cohort 3 - IV Cyclophosphamide 1.0 g/m2
n=11 participants at risk
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.0 g/m2
|
Cohort 4 - IV Cyclophosphamide 2.0 g/m2
n=3 participants at risk
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 2.0 g/m2
|
Cohort 5 - IV Cyclophosphamide 1.5 g/m2
n=3 participants at risk
SB-728-T: Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.5 g/m2
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • 1 year
|
66.7%
4/6 • 1 year
|
36.4%
4/11 • 1 year
|
33.3%
1/3 • 1 year
|
33.3%
1/3 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • 1 year
|
33.3%
2/6 • 1 year
|
18.2%
2/11 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • 1 year
|
18.2%
2/11 • 1 year
|
33.3%
1/3 • 1 year
|
33.3%
1/3 • 1 year
|
|
Gastrointestinal disorders
Abdominal discomfort
|
33.3%
1/3 • 1 year
|
0.00%
0/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/11 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Gastrointestinal disorders
Anal skin tags
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/11 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
General disorders
Chills
|
66.7%
2/3 • 1 year
|
66.7%
4/6 • 1 year
|
27.3%
3/11 • 1 year
|
100.0%
3/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
General disorders
Pyrexia
|
33.3%
1/3 • 1 year
|
33.3%
2/6 • 1 year
|
54.5%
6/11 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
General disorders
Fatigue
|
33.3%
1/3 • 1 year
|
33.3%
2/6 • 1 year
|
27.3%
3/11 • 1 year
|
0.00%
0/3 • 1 year
|
66.7%
2/3 • 1 year
|
|
General disorders
Pain
|
33.3%
1/3 • 1 year
|
16.7%
1/6 • 1 year
|
18.2%
2/11 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
General disorders
Asthenia
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • 1 year
|
9.1%
1/11 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
General disorders
Malaise
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
|
General disorders
Chest pain
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
General disorders
Temperature intolerance
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/11 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Immune system disorders
Food allergy
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/11 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
66.7%
2/3 • 1 year
|
33.3%
2/6 • 1 year
|
27.3%
3/11 • 1 year
|
66.7%
2/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • 1 year
|
18.2%
2/11 • 1 year
|
33.3%
1/3 • 1 year
|
33.3%
1/3 • 1 year
|
|
Infections and infestations
Furuncle
|
33.3%
1/3 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/11 • 1 year
|
100.0%
3/3 • 1 year
|
66.7%
2/3 • 1 year
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
33.3%
1/3 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Endocrine disorders
Hypogonadism
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Eye disorders
Scintillating scotoma
|
33.3%
1/3 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Infections and infestations
Balanitis candida
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Infections and infestations
Cellulitis staphylococcal
|
33.3%
1/3 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Infections and infestations
Chlamydial infection
|
33.3%
1/3 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/11 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Infections and infestations
Gonorrhoea
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/11 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Infections and infestations
Laryngitis
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/11 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Infections and infestations
Paronychia
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/11 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/11 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Infections and infestations
Syphilis
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/11 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Injury, poisoning and procedural complications
Exposure to communicable disease
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/11 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
18.2%
2/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
18.2%
2/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Investigations
Blood pressure decreased
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/11 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • 1 year
|
16.7%
1/6 • 1 year
|
9.1%
1/11 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • 1 year
|
0.00%
0/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/11 • 1 year
|
66.7%
2/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/11 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/11 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibrous histiocytoma
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nervous system disorder
|
66.7%
2/3 • 1 year
|
100.0%
6/6 • 1 year
|
36.4%
4/11 • 1 year
|
33.3%
1/3 • 1 year
|
66.7%
2/3 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Headache
|
66.7%
2/3 • 1 year
|
83.3%
5/6 • 1 year
|
36.4%
4/11 • 1 year
|
33.3%
1/3 • 1 year
|
33.3%
1/3 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Migraine
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dizziness
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/11 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Psychiatric disorders
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • 1 year
|
9.1%
1/11 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Agitation
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Insomnia
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Substance abuse
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/11 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Renal and urinary disorders
Respiratory, thoracic and mediastinal disorders
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • 1 year
|
36.4%
4/11 • 1 year
|
33.3%
1/3 • 1 year
|
33.3%
1/3 • 1 year
|
|
Renal and urinary disorders
Cough
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
9.1%
1/11 • 1 year
|
33.3%
1/3 • 1 year
|
33.3%
1/3 • 1 year
|
|
Renal and urinary disorders
Sinus congestion
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Renal and urinary disorders
Oropharyngeal pain
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Renal and urinary disorders
Respiratory tract congestion
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Skin odour abnormal
|
33.3%
1/3 • 1 year
|
33.3%
2/6 • 1 year
|
45.5%
5/11 • 1 year
|
66.7%
2/3 • 1 year
|
33.3%
1/3 • 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
27.3%
3/11 • 1 year
|
100.0%
3/3 • 1 year
|
100.0%
3/3 • 1 year
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/11 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/11 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia areata
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
9.1%
1/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pityriasis rubra pilaris
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/11 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
18.2%
2/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Vascular disorders
Pallor
|
0.00%
0/3 • 1 year
|
33.3%
2/6 • 1 year
|
0.00%
0/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
|
Vascular disorders
Venous thrombosis
|
33.3%
1/3 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/11 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All proposed written materials related to the study or an outline of any proposed oral presentations, shall be submitted to Sangamo for approval at least 45 days prior to submission of materials for publication or any oral disclosure to a third party. If Sangamo determines that a description of patentable subject matter is contained in such written material or outline, it shall notify the clinical site within 1 month after receipt and Sangamo will have an additional 90 days for review.
- Publication restrictions are in place
Restriction type: OTHER