Trial Outcomes & Findings for Repeat Doses of SB-728mR-T After Cyclophosphamide Conditioning in HIV-Infected Subjects on HAART (NCT NCT02225665)
NCT ID: NCT02225665
Last Updated: 2021-03-19
Results Overview
Number of Participants with Treatment related Adverse Events in subjects who received any portion of the SB-728mR-T infusion
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
8 participants
Primary outcome timeframe
12 months
Results posted on
2021-03-19
Participant Flow
Participant milestones
| Measure |
Cohort 1
SB-728mR-T infusions of 2 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)
Cyclophosphamide: - IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion
|
Cohort 2
SB-728mR-T infusions of 3 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)
Cyclophosphamide: - IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
|
Overall Study
COMPLETED
|
2
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1
SB-728mR-T infusions of 2 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)
Cyclophosphamide: - IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion
|
Cohort 2
SB-728mR-T infusions of 3 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)
Cyclophosphamide: - IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion
|
|---|---|---|
|
Overall Study
Subject moved from area and finds it difficult to return for visits.
|
1
|
0
|
|
Overall Study
Subject restarted HAART prior to month 18.
|
0
|
1
|
Baseline Characteristics
Repeat Doses of SB-728mR-T After Cyclophosphamide Conditioning in HIV-Infected Subjects on HAART
Baseline characteristics by cohort
| Measure |
Cohort 1
n=3 Participants
SB-728mR-T infusions of 2 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)
Cyclophosphamide: - IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion
|
Cohort 2
n=5 Participants
SB-728mR-T infusions of 3 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)
Cyclophosphamide: - IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.0 years
STANDARD_DEVIATION 8.19 • n=5 Participants
|
39.6 years
STANDARD_DEVIATION 10.09 • n=7 Participants
|
46.9 years
STANDARD_DEVIATION 13.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Safety Analysis Set
Number of Participants with Treatment related Adverse Events in subjects who received any portion of the SB-728mR-T infusion
Outcome measures
| Measure |
Cohort 1
n=3 Participants
SB-728mR-T infusions of 2 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)
Cyclophosphamide: - IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion
|
Cohort 2
n=5 Participants
SB-728mR-T infusions of 3 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)
Cyclophosphamide: - IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion
|
|---|---|---|
|
Primary Outcome Measure
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Safety analysis set
Effect of repeat doses of SB-728mR-T on engraftment following cyclophosphamide conditioning as measured by CCR5 Modified CD4 Cells at Month 12.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
SB-728mR-T infusions of 2 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)
Cyclophosphamide: - IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion
|
Cohort 2
n=5 Participants
SB-728mR-T infusions of 3 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)
Cyclophosphamide: - IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion
|
|---|---|---|
|
Secondary Outcome Measure
|
0.090 cells 10^9/L
Standard Deviation 0.0015
|
0.162 cells 10^9/L
Standard Deviation 0.0818
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Safety analysis set
Effect of SB-728mR-T on plasma HIV-1 RNA levels following HAART interruption
Outcome measures
| Measure |
Cohort 1
n=2 Participants
SB-728mR-T infusions of 2 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)
Cyclophosphamide: - IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion
|
Cohort 2
n=5 Participants
SB-728mR-T infusions of 3 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)
Cyclophosphamide: - IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion
|
|---|---|---|
|
Secondary Outcome Measure
|
3.218 log copies/mL
Standard Deviation 1.9243
|
1.228 log copies/mL
Standard Deviation 1.7029
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Safety analysis set
Change from baseline to month 12 in CD4+ T-cell counts in peripheral blood after repeat treatments with SB-728mR-T. (i.e. month 12 value - baseline value)
Outcome measures
| Measure |
Cohort 1
n=2 Participants
SB-728mR-T infusions of 2 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)
Cyclophosphamide: - IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion
|
Cohort 2
n=5 Participants
SB-728mR-T infusions of 3 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)
Cyclophosphamide: - IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion
|
|---|---|---|
|
Secondary Outcome Measure
|
-0.178 cells 10^9/L
Standard Deviation 0.0445
|
0.078 cells 10^9/L
Standard Deviation 0.2796
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=3 participants at risk
SB-728mR-T infusions of 2 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)
Cyclophosphamide: - IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion
|
Cohort 2
n=5 participants at risk
SB-728mR-T infusions of 3 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)
Cyclophosphamide: - IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • 1 year
|
0.00%
0/5 • 1 year
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/3 • 1 year
|
20.0%
1/5 • 1 year
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • 1 year
|
20.0%
1/5 • 1 year
|
|
General disorders
Chills
|
0.00%
0/3 • 1 year
|
20.0%
1/5 • 1 year
|
|
General disorders
Fatigue
|
0.00%
0/3 • 1 year
|
20.0%
1/5 • 1 year
|
|
General disorders
Pyrexia
|
33.3%
1/3 • 1 year
|
0.00%
0/5 • 1 year
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/3 • 1 year
|
20.0%
1/5 • 1 year
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • 1 year
|
20.0%
1/5 • 1 year
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
1/3 • 1 year
|
0.00%
0/5 • 1 year
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/3 • 1 year
|
20.0%
1/5 • 1 year
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • 1 year
|
20.0%
1/5 • 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • 1 year
|
20.0%
1/5 • 1 year
|
|
Metabolism and nutrition disorders
Cachexia
|
33.3%
1/3 • 1 year
|
0.00%
0/5 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
33.3%
1/3 • 1 year
|
0.00%
0/5 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • 1 year
|
20.0%
1/5 • 1 year
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • 1 year
|
20.0%
1/5 • 1 year
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • 1 year
|
20.0%
1/5 • 1 year
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3 • 1 year
|
20.0%
1/5 • 1 year
|
|
Renal and urinary disorders
Nephrolithiasis
|
33.3%
1/3 • 1 year
|
0.00%
0/5 • 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • 1 year
|
40.0%
2/5 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • 1 year
|
20.0%
1/5 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
0.00%
0/3 • 1 year
|
40.0%
2/5 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/3 • 1 year
|
20.0%
1/5 • 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