Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 by Sangamo Therapeutics for HIV and HIV infection. It consists of autologous T-cells that are genetically modified at the CCR5 gene using zinc finger nucleases. It is a cell-based gene therapy approach studied in HIV-infected adults.
SB-728-T targets the CCR5 gene on autologous T-cells. The T-cells are genetically modified at CCR5 using zinc finger nucleases, and the therapy is directed at HIV and HIV infection. The modification is made to the patient's own T-cells, which are then administered back to the patient.
SB-728-T is being developed by Sangamo Therapeutics, Inc., which trades under the ticker SGMOQ. Sangamo is the developer associated with the SB-728-T program in HIV and HIV infection.
SB-728-T is in Phase 1/2 clinical development. It is an investigational gene therapy for HIV and HIV infection and is not described as approved. The program has two completed clinical trials, with no active trials currently listed.
SB-728-T has been studied in completed Phase 1 and Phase 1/2 trials, including NCT01543152, a dose escalation study of cyclophosphamide in HIV-infected subjects on HAART receiving SB-728-T, and NCT01252641, a study of autologous T-cells modified at the CCR5 gene by zinc finger nucleases in HIV-infected subjects.
Across the SB-728-T clinical program, 47 patients have been enrolled in total. The trials include NCT01543152 with 26 patients, NCT01252641 with 21 patients, and NCT01044654 with 19 patients. All listed trials are completed, and none are currently active.