SB-728-T / Sangamo Therap - LARVOL DELTA

TRAILBLAZER: CCR5-modified CD4+ T Cells for HIV Infection (clinicaltrials.gov) - P1/2 | N=30 | Completed | Sponsor: University of Cincinnati | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease • CD4

Long-term Follow-up of HIV Subjects Exposed to SB-728-T or SB-728mR-T (clinicaltrials.gov) - P=N/A | N=38 | Terminated | Sponsor: Sangamo Therapeutics | Trial completion date: Jun 2035 ➔ Jul 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jun 2035 ➔ Jul 2023; There have been no significant safety issues in any subjects exposed between 7.5 and 13.5 years ago to either SB-728-T or SB-728mR-T, including no delayed adverse events related to the investigational product.

Trial completion date • Trial primary completion date • Trial termination • Human Immunodeficiency Virus • Infectious Disease

Long-term Follow-up of HIV Subjects Exposed to SB-728-T or SB-728mR-T (clinicaltrials.gov) - P=N/A | N=38 | Active, not recruiting | Sponsor: Sangamo Therapeutics | Enrolling by invitation ➔ Active, not recruiting | N=55 ➔ 38

Enrollment change • Enrollment closed • Human Immunodeficiency Virus • Infectious Disease • CD4

Long-term Follow-up of HIV Subjects Exposed to SB-728-T or SB-728mR-T (clinicaltrials.gov) - P=N/A | N=55 | Enrolling by invitation | Sponsor: Sangamo Therapeutics | Phase classification: P1 ➔ P=N/A | Trial completion date: Dec 2033 ➔ Jun 2035 | Trial primary completion date: Dec 2033 ➔ Jun 2035

Phase classification • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • CD4

TRAILBLAZER: CCR5-modified CD4+ T Cells for HIV Infection (clinicaltrials.gov) - P1/2; N=30; Active, not recruiting; Sponsor: University of Cincinnati; Recruiting ➔ Active, not recruiting

Enrollment closed • Human Immunodeficiency Virus • Infectious Disease • CD4

Long-term Follow-up of HIV Subjects Exposed to SB-728-T or SB-728mR-T (clinicaltrials.gov) - P1; N=55; Enrolling by invitation; Sponsor: Sangamo Therapeutics; Trial completion date: Dec 2031 ➔ Dec 2033; Trial primary completion date: Dec 2031 ➔ Dec 2033

Clinical • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

Repeat Doses of SB-728mR-T After Cyclophosphamide Conditioning in HIV-Infected Subjects on HAART (clinicaltrials.gov) - P1/2; N=8; Completed; Sponsor: Sangamo Therapeutics; N=12 ➔ 8

Clinical • Enrollment change • Human Immunodeficiency Virus • Immunology • Infectious Disease • CD4

Long-term Follow-up of HIV Subjects Exposed to SB-728-T or SB-728mR-T (clinicaltrials.gov) - P1; N=55; Enrolling by invitation; Sponsor: Sangamo Therapeutics

Clinical • New P1 trial

TRAILBLAZER: CCR5-modified CD4+ T Cells for HIV Infection (clinicaltrials.gov) - P1/2; N=30; Recruiting; Sponsor: Case Western Reserve University; Not yet recruiting ➔ Recruiting

Enrollment open

Repeat Doses of SB-728mR-T After Cyclophosphamide Conditioning in HIV-Infected Subjects on HAART (clinicaltrials.gov) - P1/2; N=12; Completed; Sponsor: Sangamo Therapeutics; Active, not recruiting ➔ Completed

Clinical • Trial completion

DELAYED VIRAL REBOUND DURING ATI AFTER INFUSION OF CCR5 ZFN-TREATED CD4 T CELLS (CROI 2019) - P1; "Introduction of CCR5 ZFNs via RNA transfection led to similar levels of disruption as Ad5/35 vectors. CTX led to an increase in engraftment and the administration of the product led to a modest, significant delay in viral rebound during the ATI and maintenance of low level viremia for up to 40 w in some, suggesting that a more efficient CCR5 modification could potentially benefit more individuals from this cure strategy."