Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 studied for the treatment of HIV infection. It is designed as an autologous T-cell therapy, where a patient's own T-cells are genetically modified. The therapy is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
SB-728-T targets the CCR5 gene, which encodes a co-receptor that HIV uses to enter immune cells. The therapy uses zinc finger nucleases to genetically modify a patient's T-cells at the CCR5 gene, potentially making the cells resistant to HIV infection. This mechanism is being evaluated in early-stage clinical trials.
SB-728-T is being developed by Sangamo Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol SGMO. The company is conducting Phase 1 clinical trials to evaluate the safety and efficacy of this gene therapy in patients with HIV infection.
SB-728-T is in Phase 1 clinical development. It is an investigational gene therapy for HIV infection and has not yet received regulatory approval. The therapy is still in the early stages of clinical testing, with completed Phase 1 trials evaluating its safety and biological activity in patients.
SB-728-T has been studied in three completed Phase 1 clinical trials: NCT01044654, NCT01252641, and NCT01543152. These trials evaluated the therapy in HIV-infected patients in the United States and Puerto Rico, with a total enrollment of 66 participants across the studies.
SB-728-T is an autologous T-cell therapy genetically modified at the CCR5 gene using zinc finger nucleases. It is specifically designed to disrupt CCR5 expression in a patient's own T-cells. The clinical trials for SB-728-T are titled as studies of T-cells genetically modified at the CCR5 gene.