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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sangamo Therapeutics
ClinicalTrials.gov Identifier:
NCT02225665
First received: August 22, 2014
Last updated: January 6, 2017
Last verified: January 2017
  Purpose

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.


Condition Intervention Phase
Human Immunodeficiency Virus (HIV) Genetic: SB-728mR-T Drug: Cyclophosphamide Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sangamo Therapeutics:

Primary Outcome Measures:
  • Primary Outcome Measure [ Time Frame: 12 months ]
    Treatment related Adverse Events in subjects who received any portion of the SB-728mR-T infusion


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 12
Study Start Date: August 2014
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 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)
Drug: Cyclophosphamide
- IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion
Experimental: Cohort 2 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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02225665

Locations
United States, California
Long Beach, California, United States, 90813
Palm Springs, California, United States, 92262
San Francisco, California, United States, 94115
United States, Connecticut
Norwalk, Connecticut, United States, 06850
United States, District of Columbia
Washington, District of Columbia, United States, 20009
United States, Florida
Orlando, Florida, United States, 32803
United States, New York
New York, New York, United States, 10011
United States, Texas
Austin, Texas, United States, 78705
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Sangamo Therapeutics
Investigators
Study Director: Winson Tang, MD Sangamo BioSciences, Inc.
  More Information

Responsible Party: Sangamo Therapeutics
ClinicalTrials.gov Identifier: NCT02225665     History of Changes
Other Study ID Numbers: SB-728mR-1401
Study First Received: August 22, 2014
Last Updated: January 6, 2017

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on June 23, 2017