Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01543152 | Dose Escalation Study of Cyclophosphamide in HIV-Infected Subjects on HAART Receiving SB-728-T | PHASE1 | COMPLETED | 26 | — | — | Dec 1, 2011 | Jul 7, 2017 | May 24, 2021 | 11 | United States, Puerto Rico |
| NCT01252641 | Study of Autologous T-cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases in HIV-Infected Subjects | PHASE1 | COMPLETED | 21 | — | — | Nov 1, 2010 | May 1, 2015 | Sep 20, 2019 | 4 | United States |
Number of Participants with Treatment related Adverse Events in subjects who received any portion of the SB-728-T infusion
Evaluate the safety and tolerability of a single infusion of 5-30 billion SB-728-T cells in HIV-1 positive subjects
| Arm | Type | Description |
|---|---|---|
| Cohort 1 - IV cyclophosphamide 200 mg | EXPERIMENTAL | - |
| Cohort 2 - IV cyclophosphamide 0.5 g/m2 | EXPERIMENTAL | - |
| Cohort 3 - IV cyclophosphamide 1.0 g/m2 | EXPERIMENTAL | - |
| Cohort 4 - IV cyclophosphamide 2.0 g/m2 | EXPERIMENTAL | - |
| Cohort 5 - IV cyclophosphamide 1.5 g/m2 | EXPERIMENTAL | - |
| SB-728-T | EXPERIMENTAL | Subjects will receive one intravenous infusion of SB-728-T |
| Name | Type | Description |
|---|---|---|
| SB-728-T | GENETIC | Infusion will be 5 to 30 billion ZFN modified CD4+ T cells 1 day following IV cyclophosphamide 200 mg |
Inclusion Criteria: * Male or female, 18 years of age or older with documented HIV diagnosis within 10 years of screening. * Must be willing to comply with study-mandated evaluations; including discontinuation of current antiretroviral therapy during the treatment interruption. * Must have received...