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The purpose of this study is to evaluate the safety and tolerability of repeat doses of T-cell immunotherapy (SB-728mR-T) following cyclophosphamide conditioning.
CCR5 is a major co-receptor for HIV entry into T-cells. Disruption of CCR5 by zinc finger nuclease (SB-728mR), blocks HIV entry into the T-cells, therefore, protects the T-cells from HIV infection. Safety (primary outcome) and anti-viral effect (secondary outcome) of zinc finger nuclease-mediated CCR5 disrupted autologous T-cells (SB-728mR-T) will be evaluated in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental |
| |
| Cohort 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB-728mR-T | Genetic | -SB-728mR-T infusions of 2 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measure | Number of Participants with Treatment related Adverse Events in subjects who received any portion of the SB-728mR-T infusion | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome Measure | Effect of repeat doses of SB-728mR-T on engraftment following cyclophosphamide conditioning as measured by CCR5 Modified CD4 Cells at Month 12. | 12 months |
| Secondary Outcome Measure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco | California | 94115 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Cohort 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Protocol Amendment 2 Signature page | Oct 15, 2014 |
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| SB-728mR-T | Genetic | - SB-728mR-T infusions of 3 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells) |
|
| Cyclophosphamide | Drug | - IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion |
|
Effect of SB-728mR-T on plasma HIV-1 RNA levels following HAART interruption
| 12 months |
| Secondary Outcome Measure | 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) | Baseline and 12 months |
| Norwalk |
| Connecticut |
| 06850 |
| United States |
| Orlando | Florida | 32803 | United States |
| Austin | Texas | 78705 | United States |
| Dallas | Texas | 75246 | United States |
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
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Outcome Measure | Number of Participants with Treatment related Adverse Events in subjects who received any portion of the SB-728mR-T infusion | Safety Analysis Set | Posted | Count of Participants | Participants | 12 months |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Secondary Outcome Measure | Effect of repeat doses of SB-728mR-T on engraftment following cyclophosphamide conditioning as measured by CCR5 Modified CD4 Cells at Month 12. | Safety analysis set | Posted | Mean | Standard Deviation | cells 10^9/L | 12 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Secondary Outcome Measure | Effect of SB-728mR-T on plasma HIV-1 RNA levels following HAART interruption | Safety analysis set | Posted | Mean | Standard Deviation | log copies/mL | 12 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Secondary Outcome Measure | 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) | Safety analysis set | Posted | Mean | Standard Deviation | cells 10^9/L | Baseline and 12 months |
|
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 3 | 0 | 3 | 3 | 3 |
| EG001 | 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 | 0 | 5 | 0 | 5 | 5 | 5 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastric ulcer | Gastrointestinal disorders | Systematic Assessment |
| ||
| Chest discomfort | General disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
| ||
| Chlamydial infection | Infections and infestations | Systematic Assessment |
| ||
| Conjunctivitis | Infections and infestations | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Pharyngitis streptococcal | Infections and infestations | Systematic Assessment |
| ||
| Tooth infection | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Cachexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Sciatica | Nervous system disorders | Systematic Assessment |
| ||
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin odour abnormal | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rosacea | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Monitor | Sangamo Therapeutics | 510-970-6000 | clinicaltrials@sangamo.com |
| Dec 22, 2020 |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Protocol Amendment 2 | Oct 10, 2014 | Dec 22, 2020 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 21, 2020 | Dec 22, 2020 | SAP_002.pdf |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
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