HIVPhase 1/2NCT01543152
Dose Escalation Study of Cyclophosphamide in HIV-Infected Subjects on HAART Receiving SB-728-T
A Phase 1/2 study testing SB-728-T in people with HIV, run by Sangamo Therapeutics at 11 sites in 2 countries.
Trial summary
The purpose of the study is to evaluate the safety, tolerability and effect on HIV viral load, of escalating doses of cyclophosphamide administered 1 day prior to SB-728-T infusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- SB-728-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Dec 2011to 7 Jul 2017
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 years of age or older with documented HIV diagnosis within 10 years of screening.
- Must be willing to comply with study-mandated evaluations; including discontinuation of current antiretroviral therapy during the treatment interruption.
- Must have received at least 6 months of continuous HAART therapy and have had undetectable VLs for the preceding 3 months.
- On stable antiretroviral medication (no changes to treatment within 4 weeks of screening.
- CD4+ T-cell count ≥500 cells/µL.
- Undetectable HIV-1 RNA obtained at screening.
- ANC ≥2500/µL
- Platelet count ≥200,000/µL
Who cannot join
- 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 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.
Show all 10Show fewer
- 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.
- Subjects who are currently taking maraviroc or have received maraviroc within 6 months prior to screening.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States10 sites
Central Texas Clinical Research
Austin, Texas, 78705
North Texas Infectious Diseases Consultants
Dallas, Texas, 75246
Gordon Crofoot, MD, PA
Houston, Texas, 77098
UCLA Care Center
Los Angeles, California, 90035
Ricky K Hsu, MD, PC
New York, New York, 10011
Circle CARE Center, LLC
Norwalk, Connecticut, 06850
Orlando Immunology Center
Orlando, Florida, 32803
Quest Clinical Research
San Francisco, California, 94115
Southwest CARE Center
Santa Fe, New Mexico, 87505
Central West Clinical Research, Inc.
St Louis, Missouri, 63108
About this study
Official title: A Phase I, Open-Label Study to Assess the Effect of Escalating Doses of Cyclophosphamide on the Engraftment of SB-728-T in Aviremic HIV-Infected Subjects on HAART
The purpose of the study is to evaluate the safety, tolerability and effect on HIV viral load, of escalating doses of cyclophosphamide administered 1 day prior to SB-728-T infusion.
Read the detailed description
The objectives of the study are to augment HIV-specific T-cells and to reverse or decrease the progressive destruction of CD4+ T-cells that leads to clinical AIDS. Levels of engraftment vary from negligible to about 10% of the CD4+ T-cells in the vascular compartment. Preliminary analyses of HAART TI suggest that an anti-HIV effect may correlate with the level of SB-728-T engraftment. Concurrently, non-myeloablative lymphodepletion with cyclophosphamide has been demonstrated to enhance engraftment of adoptively transferred T-cells through a variety of mechanisms. The study is being undertaken to increase SB-728-T engraftment through the administration of low non-myeloablative doses of cyclophosphamide.
- Conditions
- HIV
- Being tested
- SB-728-T
- Keywords
- HIV, autologous cell therapy, cyclophosphamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB-728-TGenetic
Also called cyclophosphamide
Infusion will be 5 to 30 billion ZFN modified CD4+ T cells 1 day following IV cyclophosphamide 200 mg
SB-728-TGenetic
Also called cyclophosphamide
Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 0.5 g/m2
SB-728-TGenetic
Also called cyclophosphamide
Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.0 g/m2
SB-728-TGenetic
Also called cyclophosphamide
Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 2.0 g/m2
SB-728-TGenetic
Also called cyclophosphamide
Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.5 g/m2
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - IV cyclophosphamide 200 mg | Experimental | Not described Receives: Genetic: SB-728-T |
| Cohort 2 - IV cyclophosphamide 0.5 g/m2 | Experimental | Not described Receives: Genetic: SB-728-T |
| Cohort 3 - IV cyclophosphamide 1.0 g/m2 | Experimental | Not described Receives: Genetic: SB-728-T |
| Cohort 4 - IV cyclophosphamide 2.0 g/m2 | Experimental | Not described Receives: Genetic: SB-728-T |
| Cohort 5 - IV cyclophosphamide 1.5 g/m2 | Experimental | Not described Receives: Genetic: SB-728-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent Adverse Events
Number of Participants with Treatment related Adverse Events in subjects who received any portion of the SB-728-T infusion
Measured: 28 days after the SB-728-T infusion of the last subject in each Cohort and up to 12 months
Secondary outcomes (3)
Effect of Escalating Doses of Cyclophosphamide on SB-728-T Engraftment as Measured by CCR5 Modified CD4 Cells in Blood.
Effect of repeat doses of SB-728-T on engraftment following cyclophosphamide conditioning as measured by CCR5 Modified CD4 Cells in blood at Month 12.
Measured: Up to 12 months after the last SB-728-T infusion
Effect of SB-728-T on Plasma HIV-1 RNA Levels Following HAART Interruption
Effect of SB-728-T on plasma HIV-1 RNA levels following HAART interruption. The unit is log copies/mL, except for the Cohort 1, the unit is " copies/mL".
Cohort 1 mean and SD are 0. All 3 subjects had NO HIV-1 RNA DETECTED.
Measured: Up to 12 months after the last SB-728-T infusion
Change From Baseline to Month 12 in CD4+ T-cell Counts in Peripheral Blood After Repeat Treatments With SB-728-T. (i.e. Month 12 Value - Baseline Value)
Change from baseline to month 12 in CD4+ T-cell counts in peripheral blood after repeat treatments with SB-728-T. (i.e. month 12 value - baseline value)
Measured: Up to 12 months after the last SB-728-T infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startDec 2011
- Primary completion7 Jul 2017
- Study completion7 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sangamo Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543152
- Sponsor's protocol ID
- SB-728-1101
- Status last verified
- Oct 2017
- First submitted
- 1 Mar 2012
- Last updated
- 24 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label Study to Assess the Effect of Escalating Doses of Cyclophosphamide on the Engraftment of SB-728-T in Aviremic HIV-Infected Subjects on HAART
- ClinicalTrials.gov ID
- NCT01543152
- Acronym / sponsor ID
- SB-728-1101
- Conditions
- HIV
- Keywords
- HIV, autologous cell therapy, cyclophosphamide
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Sangamo TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- 7 Jul 2017 (actual)
- Study completion
- 7 Jul 2017 (actual)
- First posted
- 2 Mar 2012 (estimated)
- Results
- Posted 21 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the safety, tolerability and effect on HIV viral load, of escalating doses of cyclophosphamide administered 1 day prior to SB-728-T infusion.
Detailed description
The objectives of the study are to augment HIV-specific T-cells and to reverse or decrease the progressive destruction of CD4+ T-cells that leads to clinical AIDS. Levels of engraftment vary from negligible to about 10% of the CD4+ T-cells in the vascular compartment. Preliminary analyses of HAART TI suggest that an anti-HIV effect may correlate with the level of SB-728-T engraftment. Concurrently, non-myeloablative lymphodepletion with cyclophosphamide has been demonstrated to enhance engraftment of adoptively transferred T-cells through a variety of mechanisms. The study is being undertaken to increase SB-728-T engraftment through the administration of low non-myeloablative doses of cyclophosphamide.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - IV cyclophosphamide 200 mg | Experimental | Genetic: SB-728-T |
| Cohort 2 - IV cyclophosphamide 0.5 g/m2 | Experimental | Genetic: SB-728-T |
| Cohort 3 - IV cyclophosphamide 1.0 g/m2 | Experimental | Genetic: SB-728-T |
| Cohort 4 - IV cyclophosphamide 2.0 g/m2 | Experimental | Genetic: SB-728-T |
| Cohort 5 - IV cyclophosphamide 1.5 g/m2 | Experimental | Genetic: SB-728-T |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, 18 years of age or older with documented HIV diagnosis within 10 years of screening.
- Must be willing to comply with study-mandated evaluations; including discontinuation of current antiretroviral therapy during the treatment interruption.
- Must have received at least 6 months of continuous HAART therapy and have had undetectable VLs for the preceding 3 months.
- On stable antiretroviral medication (no changes to treatment within 4 weeks of screening.
- CD4+ T-cell count ≥500 cells/µL.
Key exclusion criteria (10 listed)
- 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 arrhythmias.
- History or any features on physical examination indicative of a bleeding diathesis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SB-728-TAlso: cyclophosphamideInfusion will be 5 to 30 billion ZFN modified CD4+ T cells 1 day following IV cyclophosphamide 200 mg | Genetic | Cohort 1 - IV cyclophosphamide 200 mg |
| SB-728-TAlso: cyclophosphamideInfusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 0.5 g/m2 | Genetic | Cohort 2 - IV cyclophosphamide 0.5 g/m2 |
| SB-728-TAlso: cyclophosphamideInfusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.0 g/m2 | Genetic | Cohort 3 - IV cyclophosphamide 1.0 g/m2 |
| SB-728-TAlso: cyclophosphamideInfusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 2.0 g/m2 | Genetic | Cohort 4 - IV cyclophosphamide 2.0 g/m2 |
| SB-728-TAlso: cyclophosphamideInfusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.5 g/m2 | Genetic | Cohort 5 - IV cyclophosphamide 1.5 g/m2 |
Primary outcome
Treatment-emergent Adverse Events
Time frame: 28 days after the SB-728-T infusion of the last subject in each Cohort and up to 12 months
Number of Participants with Treatment related Adverse Events in subjects who received any portion of the SB-728-T infusion
3 secondary outcomes
Effect of Escalating Doses of Cyclophosphamide on SB-728-T Engraftment as Measured by CCR5 Modified CD4 Cells in Blood.
Time frame: Up to 12 months after the last SB-728-T infusion
Effect of SB-728-T on Plasma HIV-1 RNA Levels Following HAART Interruption
Time frame: Up to 12 months after the last SB-728-T infusion
Change From Baseline to Month 12 in CD4+ T-cell Counts in Peripheral Blood After Repeat Treatments With SB-728-T. (i.e. Month 12 Value - Baseline Value)
Time frame: Up to 12 months after the last SB-728-T infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SB-728-T in people with HIV, run by Sangamo Therapeutics at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent Adverse Events (time frame: 28 days after the SB-728-T infusion of the last subject in each Cohort and up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2021.