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Repeat Doses of SB-728mR-T After Cyclophosphamide Conditioning in HIV-Infected Subjects on HAART

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02225665
Recruitment Status : Completed
First Posted : August 26, 2014
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Sangamo Therapeutics

Tracking Information
First Submitted Date  ICMJE August 22, 2014
First Posted Date  ICMJE August 26, 2014
Last Update Posted Date July 8, 2019
Study Start Date  ICMJE August 2014
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2014)
Primary Outcome Measure [ Time Frame: 12 months ]
Treatment related Adverse Events in subjects who received any portion of the SB-728mR-T infusion
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2014)
  • Secondary Outcome Measure [ Time Frame: 12 months ]
    Effect of repeat doses of SB-728mR-T on engraftment following cyclophosphamide conditioning as measured by pentamer PCR
  • Secondary Outcome Measure [ Time Frame: 12 months ]
    Effect of SB-728mR-T on plasma HIV-1 RNA levels following HAART interruption
  • Secondary Outcome Measure [ Time Frame: 12 months ]
    Change in CD4+ T-cell counts in peripheral blood after repeat treatments with SB-728mR-T
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Repeat Doses of SB-728mR-T After Cyclophosphamide Conditioning in HIV-Infected Subjects on HAART
Official Title  ICMJE A Phase 1/2, Open-Label Study to Assess the Safety and Tolerability of Repeat Doses of Autologous T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases in HIV-Infected Subjects Following Cyclophosphamide Conditioning
Brief Summary

The purpose of this study is to evaluate the safety and tolerability of repeat doses of T-cell immunotherapy (SB-728mR-T) following cyclophosphamide conditioning.

CCR5 is a major co-receptor for HIV entry into T-cells. Disruption of CCR5 by zinc finger nuclease (SB-728mR), blocks HIV entry into the T-cells, therefore, protects the T-cells from HIV infection. Safety (primary outcome) and anti-viral effect (secondary outcome) of zinc finger nuclease-mediated CCR5 disrupted autologous T-cells (SB-728mR-T) will be evaluated in the study.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Human Immunodeficiency Virus (HIV)
Intervention  ICMJE
  • Genetic: SB-728mR-T
    -SB-728mR-T infusions of 2 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)
  • Genetic: SB-728mR-T
    - SB-728mR-T infusions of 3 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)
  • Drug: Cyclophosphamide
    - IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion
Study Arms  ICMJE
  • Experimental: Cohort 1
    Interventions:
    • Genetic: SB-728mR-T
    • Drug: Cyclophosphamide
  • Experimental: Cohort 2
    Interventions:
    • Genetic: SB-728mR-T
    • Drug: Cyclophosphamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 22, 2014)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2018
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 HIV diagnosis or suspected infection.
  • Undetectable HIV-1 RNA for at least 2 months prior to screening and at screening.
  • CD4+ T-cell count ≥500 cells/µL.
  • Absolute neutrophil count (ANC) ≥ 2500/mm3.
  • Platelet count ≥ 200,000/mm3.

Exclusion Criteria:

  • Acute or chronic hepatitis B or hepatitis C infection.
  • Active or recent (in prior 6 months) AIDS defining complication.
  • Any cancer or malignancy within the past 5 years, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin or low grade (0 or 1) anal or cervical dysplasia.
  • Current diagnosis of NYHA grade 3 or 4 CHF, uncontrolled angina or uncontrolled arrhythmias.
  • History or any features on physical examination indicative of a bleeding diathesis.
  • Received HIV experimental vaccine within 6 months prior to screening, or any previous gene therapy using an integrating vector.
  • Use of chronic corticosteroids, hydroxyurea, or immunomodulating agents within 30 days prior to screening.
  • Use of Aspirin, dipyridamole, warfarin or any other medication that is likely to affect platelet function or other aspects of blood coagulation during the 2 week period prior to leukapheresis.
  • Currently participating in another clinical trial or participation in such a trial within 30 days prior to screening visit.
  • Currently taking maraviroc or have received maraviroc within 6 months prior to screening.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02225665
Other Study ID Numbers  ICMJE SB-728mR-1401
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sangamo Therapeutics
Study Sponsor  ICMJE Sangamo Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Winson Tang, MD Sangamo BioSciences, Inc.
PRS Account Sangamo Therapeutics
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP