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Also known as cyclophosphamide
SB-728-T · 3 trials · 3 indications
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 |
| Cohort 1 | EXPERIMENTAL | 3 Subjects will receive a single infusion of 0.5-1.0 x 1010 SB-728-T |
| Cohort 2 | EXPERIMENTAL | 3 Subjects will receive a single infusion of 2.0 x 1010 SB-728-T |
| Cohort 3 | EXPERIMENTAL | 3 Subjects will receive a single infusion of 3.0 x 1010 SB-728-T |
| Cohort 4 | EXPERIMENTAL | Up to 4 HAART failure subjects will receive a single intravenous infusion of 0.5 to 3.0 x 1010 SB-728-T |
| Cohort 5 | EXPERIMENTAL | Up to 20 subjects with heterozygote CCR5 delta-32 mutation will receive a single intravenous infusion of 0.5 to 3.0 x 1010 SB-728-T. Cohort 5 subjects will undergo a structured treatment interruption 2 months following infusion in which their anti-retroviral therapy will be discontinued for 16 weeks. HAART will be reinstituted in subjects whose CD4+ cell counts drop to \<350 cells/mm3 and/or whose HIV-RNA increases to \>100,000 on three consecutive weekly measurements. At the end of the STI, subjects with a sustained detectable viral load will be reinstituted on HAART. Subjects with HIV RNA levels below the limit of detection will remain off HAART. Subjects with an undetectable viral load will remain off HAART until HIV RNA levels are detectable or their CD4 count drops below 350 cell/mm3 on three consecutive weekly measurements. |
| 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...
SB-728-T is an investigational gene therapy being developed for the treatment of HIV and HIV infection. It is designed as an autologous T-cell therapy, meaning a patient's own T-cells are modified outside the body and then returned to the patient. It has been studied in Phase 1 clinical trials in HIV-infected adults.
SB-728-T targets the CCR5 gene in autologous T-cells. The therapy uses zinc finger nucleases to genetically modify T-cells at the CCR5 gene, the co-receptor HIV uses to enter cells. The goal is to create a population of HIV-resistant T-cells. The molecular target is HIV.
SB-728-T is being developed by Sangamo Therapeutics, Inc., which trades under the ticker SGMO. Sangamo is the sponsor of the clinical trials evaluating this gene therapy approach in HIV-infected patients.
SB-728-T is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA. All completed trials of SB-728-T were Phase 1 studies, and no active trials are currently listed.
SB-728-T has been evaluated in completed Phase 1 trials including NCT01543152, a dose escalation study of cyclophosphamide in HIV-infected subjects on HAART receiving SB-728-T; NCT01252641, a study of autologous T-cells genetically modified at the CCR5 gene by zinc finger nucleases; and NCT01044654, a Phase 1 dose escalation study of similarly modified autologous T-cells in HIV-infected patients.