CS22-03NCT05784415
Observational Study of People Living With HIV Treated With CD19-directed CAR T Cell
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Record History
All 7 versions: 7 with changes below. See every version on ClinicalTrials.gov ↗
Notable Results posted: Oct 28, 2026 Show 4 more changesShow less
- Enrollment target: 30 to 35
- Secondary endpoints: 5 to 14
- Primary endpoint revised
- Eligibility criteria expanded, about 3 words
- Notable Start date: Feb 16, 2021 to May 22, 2021
- Trial status: Active, Not Recruiting to Completed
- Primary completion date changed from estimate of Aug 4, 2025 to Nov 14, 2024
- Study completion date changed from estimate of Aug 31, 2025 to Nov 14, 2024
- Notable Primary completion date: Feb 4, 2024 to Aug 4, 2025v5
- Notable Primary completion date: Feb 1, 2023 to Feb 4, 2024v4
- Minor Start date: Apr 7, 2022 to Feb 16, 2021v3
- Minor Trial status: Recruiting to Active, Not Recruiting
- Primary completion date changed from estimate of Aug 31, 2024 to Feb 1, 2023
- Site details revised
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Rate of Toxicities Related to CAR19 Therapy
Timeframe: 12 months
Secondary (14)
Overall Response
Complete Remission
CD8 Count at 3 Months Post CAR-T
CD8 Count at 6 Months Post CAR-T
CD8 Count at 9 Months Post-CAR T
Show 9 moreShow less
CD8 Count at 12 Months Post-CAR T
HIV Viral Load at 3 Months Post-CAR T
HIV Viral Load at 6 Months Post-CAR T
HIV Viral Load at 9 Months Post-CAR T
HIV Viral Load at 12 Months Post-CAR T
Neutrophil Recovery
Platelet Recovery
Overall Survival
Progression-free Survival
Arms and interventions
Observational
Clinical information on participants, who carry a diagnosis of HIV disease AND received CAR19 therapy outside of a clinical trial between August 30, 2017 and August 31, 2021 will be captured
Sites
1 site in 1 country
- Pennsylvania HospitalPhiladelphia, Pennsylvania, United States