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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00842634Autologous T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases SB-728 for HIVPHASE1 COMPLETED 12 — — Jan 1, 2009Jan 1, 2013Feb 8, 20192 United States
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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 — 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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