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SB-728mR-T

Phase 1

Human Immunodeficiency Virus (HIV) | Gene therapy | Infectious Disease |Sangamo Therapeutics, Inc.|Last Updated: Mar 19, 2021

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02225665Repeat Doses of SB-728mR-T After Cyclophosphamide Conditioning in HIV-Infected Subjects on HAARTPHASE1 COMPLETED 8Aug 1, 2014Jun 1, 2018Mar 19, 20215 United States
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Study Endpoints
Primary Endpoints
Primary Outcome Measure
12 months

Number of Participants with Treatment related Adverse Events in subjects who received any portion of the SB-728mR-T infusion

Secondary Endpoints
Secondary Outcome Measure
12 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTAL -
Cohort 2EXPERIMENTAL -
Interventions
NameTypeDescription
SB-728mR-TGENETIC-SB-728mR-T infusions of 2 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)
CyclophosphamideDRUG\- IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Male or female, 18 years of age or older with documented HIV diagnosis. * Must be willing to comply with study-mandated evaluations; including discontinuation of current antiretroviral therapy during the treatment interruption. * Initiated HAART therapy within (≤) 1 year of HI...

Countries:United States
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