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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 being studied for the treatment of HIV and HIV infections. The approach uses autologous T cells, meaning a patient's own T cells, that are genetically modified and then returned to the patient. Sangamo Therapeutics is developing this therapy, which has been tested in a Phase 1 trial.
ZFN modified T cells are being developed by Sangamo Therapeutics, Inc., which trades on the Nasdaq under the ticker symbol SGMO. Sangamo is a clinical-stage biotechnology company focused on genomic medicines, and this HIV cell therapy is part of its pipeline.
ZFN modified T cells are in Phase 1 clinical development. The only reported trial, NCT00842634, has been completed. The therapy is investigational and has not been approved by the FDA for any indication. It was studied in a small trial that enrolled 12 participants.
ZFN modified T cells have been evaluated in one completed Phase 1 trial, NCT00842634, titled "Autologous T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases SB-728 for HIV." The trial enrolled 12 participants with HIV or HIV infections in the United States. It was a controlled study without randomization or double-blinding.
ZFN modified T cells are created by genetically modifying a patient's own T cells at the CCR5 gene using zinc finger nucleases (ZFNs). The CCR5 gene encodes a co-receptor that HIV uses to enter cells. Disrupting CCR5 is intended to make the modified T cells resistant to HIV infection.