Dose Escalation Study of Cyclophosphamide in HIV-Infected Subjects on HAART Receiving SB-728-T

NCT01543152 | Completed Phase 1 Results DMC

• 1 other identifier: SB-728-1101
• Study Type: interventional
• Target: 26
• Locations: 2 countries
• Sites: 11

Brief 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.

Conditions

HIV

Keywords

HIV; autologous cell therapy; cyclophosphamide

Outcome Measures

Primary Outcomes (1)

• Treatment-emergent Adverse Events

  Number of Participants with Treatment related Adverse Events in subjects who received any portion of the SB-728-T infusion

  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.

  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

  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)

  Up to 12 months after the last SB-728-T infusion

Study Arms (5)

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

Interventions

SB-728-T GENETIC

Infusion will be 5 to 30 billion ZFN modified CD4+ T cells 1 day following IV cyclophosphamide 200 mg

Also known as: cyclophosphamide

Cohort 1 - IV cyclophosphamide 200 mg

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sangamo Therapeutics: lead

Study Sites (11)

UCLA Care Center

Los Angeles, California, 90035, United States

Location

Quest Clinical Research

San Francisco, California, 94115, United States

Location

Circle CARE Center, LLC

Norwalk, Connecticut, 06850, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

Central West Clinical Research, Inc.

St Louis, Missouri, 63108, United States

Location

Southwest CARE Center

Santa Fe, New Mexico, 87505, United States

Location

Ricky K Hsu, MD, PC

New York, New York, 10011, United States

Location

Central Texas Clinical Research

Austin, Texas, 78705, United States

Location

North Texas Infectious Diseases Consultants

Dallas, Texas, 75246, United States

Location

Gordon Crofoot, MD, PA

Houston, Texas, 77098, United States

Location

Clinical Research Puerto Rico

San Juan, 00909, Puerto Rico

Location

MeSH Terms

Interventions

Cyclophosphamide

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Medical Monitor
• Organization: Sangamo Therapeutics

clinicaltrials@sangamo.com

510-970-6000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: March 2, 2012
• Study Start: December 1, 2011
• Primary Completion: July 7, 2017
• Study Completion: July 7, 2017
• Last Updated: May 24, 2021
• Results First Posted: April 21, 2021

Record last verified: 2017-10

Locations

PR (1); US (10)