Sponsor decision to discontinue the study; the study is no longer being pursued due to sponsor strategic reprioritization and resource allocation. The decision was not based on safety concerns. Enrolled participants will complete safety follow-up per
A Pilot Study of EBV-TCR-T Cells in EB Virus Infection Diseases After HSCT
Sponsor study identifier
interventional
18
1 country
1
Study Start
February 10, 2020
Actual (reported)Primary Completion
July 30, 2021
Actual (reported)Study Completion
October 31, 2021
Actual (reported)This is a single center, single arm, open-label, phase I study to evaluate the safety and efficacy of EBV-TCR-T cells in patients with EB virus infection after HSCT.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 4, 2019
Actual (reported)November 7, 2019
Actual (reported)February 10, 2020
Actual (reported)July 30, 2021
Actual (reported)October 31, 2021
Actual (reported)Percentage of adverse events
Percentage of participants with adverse events.
3months
Proliferation ratio of TCR-T cells
3months
changes of EBV-DNA copies
3months
Patients with EBV emias or EBV positive PTLD will be enrolled, and donor derived EBV-TCR-T(HLA-A\*1101\\0201\\2402) cells will be intravenously infused with a escalated dose of 0.1-1×106 EBV-TCR-T cells. The EBV DNA copies and EBV-TCR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14, day 28).
EBV-TCR-T cells are prepared via lentiviral infection. patients with EBV emias or EBV positive PTLD will be enrolled, and donor derived EBV-TCR-T(HLA-A\*1101\\0201\\2402) cells will be intravenously infused with a escalated dose of 0.1-1×106 EBV-TCR-T cells. The EBV DNA copies and EBV-TCR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14, day 28).
Hebei Yanda Ludaopei Hospital
Sanhe, Hebei, 065200, China
18 participants (actual enrollment reported by the registry).
First Submitted
November 4, 2019
First Posted
November 7, 2019
Study Start
February 10, 2020
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
July 30, 2021
Actual (reported)Study Completion
October 31, 2021
Actual (reported)Last Updated
October 29, 2026
Record last verified: 2021-08
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Source: ClinicalTrials.gov.
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