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Gene Therapy
Gene-Edited Stem Cell Therapy for HIV/AIDS
Phase 1
Waitlist Available
Led By Amrita Y. Krishnan, MD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Maximum age 75 years for cohort 1 and 65 years for cohort 2
HIV-1 R5 seropositive with no evidence of CXCR4-tropic virus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to year 5
Awards & highlights
Study Summary
This trial will test whether it is safe to give a person with leukemia a new treatment that uses their own stem cells.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include reactions related to the infusion process itself and complications from busulfan conditioning like lowered blood counts leading to increased infection risk. Genetic modification might also pose risks that will be closely monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 75 or younger for cohort 1, and 65 or younger for cohort 2.
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I am HIV positive with only the R5 virus strain.
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I have been on HIV treatment with undetectable levels for at least a year.
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I do not have serious heart disease or heart failure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to year 5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to year 5
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Toxicity in subjects who received SB-728mR-HSPC after each busulfan dose level
Secondary outcome measures
Number of CD34+ HSPC collected, gene modified, and released throughout the manufacturing process
Other outcome measures
Changes in CD4+ T-cell number after SB-728mR-HSPC infusion
Changes in CD4+ T-cell percentage after SB-728mR-HSPC infusion
Changes in CD4/CD8 ratio after SB-728mR-HSPC infusion
+6 moreTrial Design
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)
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
570 Previous Clinical Trials
1,922,604 Total Patients Enrolled
Sangamo TherapeuticsIndustry Sponsor
28 Previous Clinical Trials
937 Total Patients Enrolled
California Institute for Regenerative Medicine (CIRM)OTHER
65 Previous Clinical Trials
3,163 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 75 or younger for cohort 1, and 65 or younger for cohort 2.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.I am HIV positive with only the R5 virus strain.I have been on HIV treatment with undetectable levels for at least a year.I have a current cancer, but skin cancers or any cancer treated successfully over 2 years ago are exceptions.I am currently using or have used steroids or drugs that affect the immune system.I have previously received an HIV vaccine or gene therapy.I am not currently on any experimental treatments or have been in a drug/device study in the last 45 days.I do not have active hepatitis B or C, and if previously infected, I have no liver cirrhosis.You have had a problem with drinking alcohol or using drugs in the past year.I have an active CMV infection affecting my eyes or other organs.I am taking AZT or maraviroc in my HIV treatment.I do not have serious heart disease or heart failure.I have a history of serious blood disorders.My virus is CXCR4-tropic.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1:
- Group 2: Cohort 2:
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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