Safety Study of Zinc Finger Nuclease CCR5-modified Hematopoietic Stem/Progenitor Cells in HIV-1 I… (NCT02500849) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Safety Study of Zinc Finger Nuclease CCR5-modified Hematopoietic Stem/Progenitor Cells in HIV-1 Infected Patients
United States12 participantsStarted 2016-03-10
Plain-language summary
The purpose of the study is to evaluate the safety and feasibility of administering SB-728mR-HSPC after conditioning with busulfan.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Maximum age 75 years for cohort 1 and 65 years for cohort 2.
* HIV-1 R5 seropositive with no evidence of CXCR4-tropic virus.
* On cART with undetectable HIV-1 (\<20 gc/ml HIV-1 RNA) for at least 12 months prior to screening evaluations.
* CD4+ T-cell counts ≥200 cells/µL and ≤750 cells/µL.
* No psychosocial conditions that would hinder study compliance and follow-up.
* Absence of clinically significant cardiomyopathy, congestive heart failure.
Secondary Eligibility Criteria (for registration):
* Complete G-CSF/Plerixafor mobilization of HSPC.
* Collect ≥7.5 x 10\^6 CD34+ cells/kg in two aphereses.
* The SB-728mR-HSPC product passed all release testing
Exclusion Criteria:
* Use of AZT or maraviroc in the cART regimen.
* History of significant hematologic diseases such as leukemia, myelodysplasia, coagulopathy, and thromboembolism.
* Any AIDS-related opportunistic infection occurring within the past year such as tuberculosis, cryptococcosis and for which treatment has been unsuccessful as determined by the Principal Investigator.
* AIDS-related syndromes, infectious or otherwise, if perceived to cause excessive risk for morbidity post-HSPC infusion, as determined by the Principal Investigator.
* Patients with active HBV or HCV infection, i.e., HBV DNA and HCV RNA in blood, are excluded. Those with inactive, but past infection with HBV (positive HBV surface antigen or HBV surface antibody) or inactive HCV (positive HCV antibody), must have no cirrhosis…
What they're measuring
1
Toxicity in subjects who received SB-728mR-HSPC after each busulfan dose level