Long-term Follow-up of HIV Subjects Exposed to SB-728-T or SB-728mR-T

Sponsor

Sangamo Therapeutics (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04201782

Collaborator

(none)

Enrollment

Locations

Arm

273.5

Anticipated Duration (Months)

13.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Long-term follow-up of HIV-infected subjects who received SB-728-T or SB-728mR-T in a previous trial and completed 3 years of post-infusion follow-up. Enrolling subjects will be followed for a total of 12 years.

Condition or Disease	Intervention/Treatment	Phase
HIV-1-infection	Drug: There are no disallowed treatments	Phase 1

Detailed Description

Subjects infected with HIV who have received therapy with SB-728-T or SB-728mR-T and have completed 3 years of post-infusion follow-up will be eligible to participate in this trial. There will be no treatment in this long-term follow-up study. Subjects who choose to enroll into this extension study will be evaluated for a total of 12 years.

An optional leukapheresis may be performed upon sponsor request.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

55 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Long-Term Follow-up of HIV-Infected Subjects Treated With Autologous T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases (SB-728-T or SB-728mR-T)

Actual Study Start Date :

Mar 18, 2011

Anticipated Primary Completion Date :

Dec 31, 2033

Anticipated Study Completion Date :

Dec 31, 2033

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 Long-term follow-up of HIV-infected subjects who received SB-728-T or SB-728mR-T in a previous trial.	Drug: There are no disallowed treatments Genetic: SB-728-T or SB-728mR-T No study drug is administered in this study. Subjects who received SB-728-T or SB-728mR-T in a previous trial will be evaluated in this trial for long-term safety and efficacy.

Arm

Intervention/Treatment

Experimental: Cohort 1

Long-term follow-up of HIV-infected subjects who received SB-728-T or SB-728mR-T in a previous trial.

Drug: There are no disallowed treatments

Genetic: SB-728-T or SB-728mR-T No study drug is administered in this study. Subjects who received SB-728-T or SB-728mR-T in a previous trial will be evaluated in this trial for long-term safety and efficacy.

Outcome Measures

Primary Outcome Measures

Long-term safety of treatment with SB-728-T or SB-728mR-T [12 years]
Number of subjects with delayed adverse events associated with administration of SB-728-T or SB-728mR-T, autologous T-cells genetically modified at the CCR5 gene by zinc finger nucleases.

Secondary Outcome Measures

Long-term persistence of SB-728-T or SB-728mR-T [2 years]
Long-term persistence of SB-728-T or SB-728mR-T will be measured by serial measurement of CCR5 gene modification.

Other Outcome Measures

Change in HIV reservoirs [2 years]
Change in HIV reservoirs will be measured by serial measurement of HIV-1 RNA, HIV proviral DNA and HIV Co-receptor Tropism

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects who have, in previous Sangamo clinical trial received SB-728-T or SB-728mR-T, autologous T-cells genetically modified at the CCR5 gene by zinc finger nucleases, have completed 3 years of post-infusion follow-up, and give consent to participate in the long-term follow-up study.

Exclusion Criteria:

There are no exclusion criteria for this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Quest Clinical Research	San Francisco	California	United States	94115
2	Circle CARE Center, LLC	Norwalk	Connecticut	United States	06850
3	Orlando Immunology Center	Orlando	Florida	United States	32803
4	Central Texas Clinical Research	Austin	Texas	United States	78705

Sponsors and Collaborators

Sangamo Therapeutics

Investigators

Study Director: Medical Monitor, Sangamo Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sangamo Therapeutics

ClinicalTrials.gov Identifier:

NCT04201782

Other Study ID Numbers:

SB-728-1003

First Posted:

Dec 17, 2019

Last Update Posted:

Jul 29, 2021

Last Verified:

Feb 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sangamo Therapeutics

HIV

gene editing

CCR5

Study Results

No Results Posted as of Jul 29, 2021