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ZFN modified T cells · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Patients who have failed two more HAART regimens |
| Cohort 2 | EXPERIMENTAL | Patients doing well on a stable antiretroviral medication |
| Cohort 3 | EXPERIMENTAL | Patients who have an undetectable viral load on HAART who have exhibited suboptimal CD4+ T cell gains during long term antiretroviral therapy. This group will not participate in the structured treatment interruption. |
| Name | Type | Description |
|---|---|---|
| ZFN modified T cells | BIOLOGICAL | A single infusion of 5-10 billion ZFN Modified CD4+ T Cells |
| Structured Treatment Interruption | OTHER | Stop Taking HAART Medication for up to 12 weeks (4 weeks after infusion to 16 weeks after infusion) |
Inclusion Criteria: Cohort 1 Only: * Patients who have been on two more HAART regimens and have failed due to resistance or tolerance (no changes to treatment within 4 weeks of study entry), and who have no viable treatment options likely to result in complete viral suppression. * CD4+ T cell coun...
ZFN modified T cells are an investigational cell therapy in which a patient's own T cells are genetically modified at the CCR5 gene using zinc finger nucleases, known as SB-728. Sangamo Therapeutics developed the approach for HIV, and it was studied in a single completed Phase 1 trial.
ZFN modified T cells were developed for HIV and HIV infections. The approach uses autologous T cells genetically modified at the CCR5 gene by zinc finger nucleases, designated SB-728. The only clinical trial of this therapy enrolled 12 participants with HIV in the United States.
ZFN modified T cells target the CCR5 gene. Zinc finger nucleases are used to genetically modify a patient's own T cells at that gene, and the resulting product is called SB-728. CCR5 is the intended genetic target of the editing step in this autologous cell therapy.
ZFN modified T cells were developed by Sangamo Therapeutics, Inc., which trades under the ticker SGMOQ. The company's zinc finger nuclease platform was applied to modify autologous T cells at the CCR5 gene, and the resulting candidate is referred to as SB-728.
ZFN modified T cells are in Phase 1. The program's single clinical trial, NCT00842634, is a completed Phase 1 study, and the therapy remains investigational rather than an approved treatment. The trial enrolled 12 participants and was conducted in the United States.
ZFN modified T cells were studied in one clinical trial, NCT00842634, titled Autologous T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases SB-728 for HIV. The Phase 1 study enrolled 12 participants aged 18 years and older with HIV or HIV infections, and it is completed.