Study of Autologous T-cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases in HIV-Infected Subjects

NCT01252641 | Completed Phase 1

• 1 other identifier: SB-728-1002
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 4

Brief Summary

This research study is being carried out to study a new way to possibly treat human immunodeficiency virus (HIV). The agent is called SB-728-T which are CD4+ T-cells obtained from an individual that are genetically modified at the CCR5 gene by Zinc Finger Nucleases. The CCR5 gene is required for certain types of HIV to enter into and infect T-cells. T cells are one of the white blood cells used by the body to fight HIV. The most important of these are called "CD4+ T-cells" Some people are born without the CCR5 gene on their T-Cells. These people remain healthy and are resistant to infection with HIV. Other people have a low number of CCR5 genes on their T-cells and their HIV disease is less severe and is slower to cause disease (AIDS). The purpose of this research study is to find out whether SB-728-T is safe to give to humans and find out how this affects HIV.

Conditions

HIV; HIV Infection

Keywords

HIV

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety and tolerability of SB-728-T cells infusion in HIV-1 positive subjects

  Evaluate the safety and tolerability of a single infusion of 5-30 billion SB-728-T cells in HIV-1 positive subjects

  12 months

Secondary Outcomes (3)

• Evaluate persistence of HIV as measured by HIV-1 RNA,

  12 months

• Change in CD4+ T-cell count

  12 months

• Persistence of SB-728-T in the peripheral blood

  12 months

Study Arms (1)

SB-728-T

EXPERIMENTAL

Subjects will receive one intravenous infusion of SB-728-T

Biological: SB-728-T

Interventions

SB-728-T BIOLOGICAL

Each infusion will be 5-30 billion modified CD4+ T-cells

SB-728-T

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented HIV infection
• CD4+ T-cell count \>500 cell per millimeter cubed (cells/mm3)
• CD4+ T-cell nadir of \>400 cells/mm3
• HIV viral load \>1,000 copies per milliliter (mL)

You may not qualify if:

• Any viral hepatitis
• Acute HIV infection
• HIV viral load \>1,000,000 copies/mL
• Active or recent (prior 6 months) AIDS defining complication
• Any HIV medications within the past 12 weeks
• Cancer or malignancy that has not been in remission for at least 5 years with the exception of successfully treated basal cell carcinoma of the skin
• Current diagnosis of NYHA grade 3 or 4 congestive heart failure or uncontrolled angina or arrhythmias
• History of bleeding problems
• Use of chronic steroids in past 30 days
• Pregnant or breast feeding
• Active drug or alcohol abuse
• Serious illness in past 30 days
• Currently participating in another clinical trail or any prior gene therapy

Sponsors & Collaborators

• Sangamo Therapeutics: lead

Study Sites (4)

UCLA CARE Center

Los Angeles, California, 90035, United States

Location

Orange Coast Medical Group

Newport Beach, California, 92663, United States

Location

Quest Clinical Research

San Francisco, California, 94115, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Winson Tang, M.D.

  Sangamo BioSciences, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2010
• First Posted: December 3, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: May 1, 2015
• Last Updated: September 20, 2019

Record last verified: 2019-09

Locations

US (4)