NCT06119256|RecruitingPhase 1DMC
Clinical Study of EBV-TCR-T Cells for EBV Infection After Allogenic HSCT
Multicenter, Open Label, Single-arm Exploratory Clinical Study of EBV-TCR-T Cells for EBV Infection After Allogenic HSCT
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Sponsor study identifier
interventional
12
1 country
1
Study Start
August 1, 2023
Actual (reported)Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This is a multi-center, single arm, open-label, phase I study to determine the safety and effectiveness of EBV-TCR-T cell immunotherapy in treating EBV virus infection after allogenic HSCT.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1, 2023
Actual (reported)October 21, 2023
Actual (reported)November 7, 2023
Actual (reported)December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Adverse events
Percentage of participants with adverse events.
1 year after EBV-TCR-T treatment
Changes of EBV-DNA copies number
1 year after EBV-TCR-T treatment
Persistence of EBV-TCR-T cells
1 year after EBV-TCR-T treatment
Dose-limiting toxicity
28 days after EBV-TCR-T treatment
Maximum tolerated dose
28 days after EBV-TCR-T treatment
The proportion of EBV-DNA negative patients
180 days after EBV-TCR-T treatment
Phase 1 trail: The patients with EBV infection after HSCT will receive one to three infusions of donor-derived EBV-TCR-T cells, with the escalated dose ranging from 5×10\^5/kg to 1×10\^6/kg EBV-TCR-T cells per dose. Phase 2 trail: According to the PK and response data, the dose escalation phase will be carried out.
The patients with EBV infection after HSCT will receive one to three infusions of donor-derived EBV-TCR-T cells, with the escalated dose ranging from 5×10\^5/kg to 1×10\^6/kg EBV-TCR-T cells per dose.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Daihong Liu, Doctor
Chinese PLA General Hospital
First Submitted
October 21, 2023
First Posted
November 7, 2023
Study Start
August 1, 2023
Actual (reported)Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 2, 2026
Record last verified: 2026-03
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Source: ClinicalTrials.gov.
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