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SB-728mR-T

Phase 1/2

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

SB-728mR-T development status

Highest phase Phase 1/2
Registered trials 1 across 1 sponsor since Aug 2014

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

SB-728mR-T clinical trials

SB-728mR-T · 1 trial · 1 indication

Phase 1/2 1
NCT02225665Repeat Doses of SB-728mR-T After Cyclophosphamide Conditioning in HIV-Infected Subjects on HAARTHuman Immunodeficiency Virus (HIV)
COMPLETED8 Analytics
PHASE1/PHASE2COMPLETED
Repeat Doses of SB-728mR-T After Cyclophosphamide Conditioning in HIV-Infected Subjects on HAART
Human Immunodeficiency Virus (HIV)Unlock trial analytics

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 to 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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Frequently asked questions about SB-728mR-T

What is SB-728mR-T?

SB-728mR-T is an investigational gene therapy developed by Sangamo Therapeutics for human immunodeficiency virus (HIV). It is a cell-based approach studied in HIV-infected adults who are on HAART (highly active antiretroviral therapy). It has been evaluated in a single completed Phase 1/2 clinical trial.

What is SB-728mR-T used for in HIV?

SB-728mR-T is being studied as a treatment for HIV infection in adults who remain on HAART. The research explores whether repeat doses of the therapy, given after cyclophosphamide conditioning, can be administered to HIV-infected subjects. It is investigational and has not been established as a marketed treatment.

Who makes SB-728mR-T?

SB-728mR-T is developed by Sangamo Therapeutics, Inc., a biopharmaceutical company whose common stock trades under the ticker SGMOQ. Sangamo is the sponsor of the clinical program evaluating the therapy in HIV.

What phase is SB-728mR-T in?

SB-728mR-T is in Phase 1/2 clinical development. Its only recorded trial, NCT02225665, is a Phase 1/Phase 2 study that has been completed. The therapy is investigational and is not an approved product.

What clinical trial is SB-728mR-T in?

SB-728mR-T has been studied in trial NCT02225665, titled "Repeat Doses of SB-728mR-T After Cyclophosphamide Conditioning in HIV-Infected Subjects on HAART." The Phase 1/Phase 2 trial enrolled 8 participants in the United States, included both sexes, accepted adults 18 years and older, and is completed.