Repeat Doses of SB-728mR-T After Cyclophosphamide Conditioning in HIV-Infected Subjects on HAART
This study is ongoing, but not recruiting participants.
Sponsor:
Sangamo Therapeutics
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Cyclophosphamide
U.S. FDA Resources
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
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 July 17, 2017


IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
