Gene-Edited Stem Cell Therapy for HIV/AIDS

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byAmrita Y. Krishnan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of the study is to evaluate the safety and feasibility of administering SB-728mR-HSPC after conditioning with busulfan.

Eligibility Criteria

This trial is for HIV-1 infected patients under 75 years old, with controlled virus levels due to consistent antiretroviral therapy (cART) for at least a year, and specific CD4+ T-cell counts. They must not have significant heart issues or psychosocial conditions affecting study participation. Excluded are those with active hepatitis, pregnant or nursing women, recent investigational drug use, substance abuse history, certain hematologic diseases, recent opportunistic infections or malignancies.

Inclusion Criteria

I am 75 or younger for cohort 1, and 65 or younger for cohort 2.

I am HIV positive with only the R5 virus strain.

I have been on HIV treatment with undetectable levels for at least a year.

+3 more

Exclusion Criteria

I have had an AIDS-related infection in the last year that hasn't improved with treatment.

You have a condition related to AIDS or other infections that could increase the risk of complications after the treatment, as decided by the main doctor in charge.

Any history of HIV-associated encephalopathy; dementia of any kind; seizures in the past 12 months; any perceived inability to directly provide informed consent

+11 more

Participant Groups

The trial tests the safety of SB-728mR-HSPC infusion in HIV/AIDS patients after busulfan conditioning. SB-728mR-HSPC is a genetically modified stem/progenitor cell product aimed at altering the immune system to resist HIV more effectively.

2Treatment groups

Experimental Treatment

Group I: Cohort 2:Experimental Treatment1 Intervention

busulfan AUC levels: 12,000 µM\*min (+/- 1,000)

Group II: Cohort 1:Experimental Treatment1 Intervention

target busulfan AUC levels: 8,000 µM\*min (+/- 1,000)