Repeat Doses of SB-728mR-T After Cyclophosphamide Conditioning in HIV-Infected Subjects on HAART

NCT02225665 | Completed Phase 1 Results

• 1 other identifier: SB-728mR-1401
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Human Immunodeficiency Virus (HIV)

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure

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

  12 months

Secondary Outcomes (3)

• Secondary Outcome Measure

  12 months

• Secondary Outcome Measure

  12 months

• Secondary Outcome Measure

  Baseline and 12 months

Study Arms (2)

Cohort 1

EXPERIMENTAL

Genetic: SB-728mR-T; Drug: Cyclophosphamide

Cohort 2

EXPERIMENTAL

Genetic: SB-728mR-T; Drug: Cyclophosphamide

Interventions

SB-728mR-T GENETIC

-SB-728mR-T infusions of 2 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)

Cohort 1

Cyclophosphamide DRUG

\- IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion

Cohort 1; Cohort 2

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.
• 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.

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 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.

Sponsors & Collaborators

• Sangamo Therapeutics: lead

Study Sites (5)

Unknown Facility

San Francisco, California, 94115, United States

Location

Unknown Facility

Norwalk, Connecticut, 06850, United States

Location

Unknown Facility

Orlando, Florida, 32803, United States

Location

Unknown Facility

Austin, Texas, 78705, United States

Location

Unknown Facility

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

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: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2014
• First Posted: August 26, 2014
• Study Start: August 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: March 19, 2021
• Results First Posted: February 9, 2021

Record last verified: 2020-12

Locations

US (5)