Repeat Doses of SB-728mR-T After Cyclophosphamide Conditioning in HIV-Infected Subjects on HAART
Status: | Active, not recruiting |
---|---|
Conditions: | HIV / AIDS, HIV / AIDS, HIV / AIDS |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | August 2014 |
End Date: | June 2018 |
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
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.
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.
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.
We found this trial at
10
sites
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