Phase 2
N=8
Repeat Doses of SB-728mR-T After Cyclophosphamide Conditioning in HIV-Infected Subjects on HAART
Human Immunodeficiency Virus (HIV)
Bottom Line
View on ClinicalTrials.gov: NCT02225665 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Primary Outcome Measure — 1; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SB-728mR-T (Genetic); Cyclophosphamide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sangamo Therapeutics
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Outcome Measure |
1; 2 | — |
| SECONDARY Secondary Outcome Measure |
-0.178; 0.078 | — |
| SECONDARY Secondary Outcome Measure |
-0.178; 0.078 | — |
| SECONDARY Secondary Outcome Measure |
-0.178; 0.078 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02225665). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.