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ZFN modified T cells

Phase 1

HIV | Monoclonal antibody | Infectious Disease |Sangamo Therapeutics, Inc.|Last Updated: Feb 8, 2019

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

ZFN modified T cells · 1 trial · 2 indications

Phase 1 1
NCT00842634Autologous T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases SB-728 for HIVHIV
COMPLETED12 Analytics
PHASE1COMPLETED
Autologous T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases SB-728 for HIV
HIV
NCT0084263412
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Study Endpoints

Primary Endpoints

Safety - Treatment related adverse events
Cohort 1, Cohort 3 approximately 1 year from screening. Cohort 2 approximately 40 weeks from screening

Secondary Endpoints

Compare the percent of CD4+ and CD8+ T cells that secrete cytokines as a response to stimulation by HIV-specific antigens after the infusion of αCCR5 ZFN-modified autologous T cells
8 weeks after the infusion of αCCR5 ZFN-modified autologous T cells
Compare the CD4+ and CD8+ T cells response following stimulation by HIVspecific antigens, at baseline and 8 weeks after the infusion of CCR5 ZFN-modified autologous T cells.
8 weeks after the infusion of CCR5 ZFN-modified autologous T cells
To evaluate the change between baseline CD4+ T-cell count and the average of two consecutive CD4+ T-cell count values after dosing and just prior to initiation of a new drug regimen or at weeks 8 and 12, whichever comes first.
week 8 or 12
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALPatients who have failed two more HAART regimens
Cohort 2EXPERIMENTALPatients doing well on a stable antiretroviral medication
Cohort 3EXPERIMENTALPatients 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.

Interventions

NameTypeDescription
ZFN modified T cellsBIOLOGICALA single infusion of 5-10 billion ZFN Modified CD4+ T Cells
Structured Treatment InterruptionOTHERStop Taking HAART Medication for up to 12 weeks (4 weeks after infusion to 16 weeks after infusion)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

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...

Countries:United States
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Frequently asked questions about ZFN modified T cells

What is ZFN modified T cells used for in HIV?

ZFN modified T cells is an investigational cell therapy being studied for the treatment of HIV and HIV infections. It involves genetically modifying a patient's own T cells at the CCR5 gene using zinc finger nucleases, with the goal of making the cells resistant to HIV entry. The therapy is currently in Phase 1 clinical development.

Who makes ZFN modified T cells?

ZFN modified T cells is being developed by Sangamo Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol SGMO. The company is conducting clinical research on this investigational therapy for HIV, though it remains in early-stage development and is not yet approved for commercial use.

What phase is ZFN modified T cells in?

ZFN modified T cells is in Phase 1 clinical development for HIV. This represents the earliest stage of human testing, focused primarily on assessing safety and preliminary efficacy. The therapy is investigational and has not received regulatory approval, and it remains under evaluation in clinical trials.

What clinical trials is ZFN modified T cells in?

ZFN modified T cells has been studied in one completed Phase 1 clinical trial, registered as NCT00842634. This trial, titled 'Autologous T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases SB-728 for HIV,' enrolled 12 participants in the United States. The study was controlled but not randomized or double-blinded, and it included biomarker-selected patients.

How does ZFN modified T cells work?

ZFN modified T cells works by using zinc finger nucleases to genetically modify a patient's own T cells at the CCR5 gene. This modification is intended to disrupt CCR5, a co-receptor that HIV uses to enter cells, potentially making the modified T cells resistant to HIV infection. The approach is being evaluated as a potential therapy for HIV.