EBV-TCR-T Cells for EB Virus Infection After HSCT

  • STATUS
    Recruiting
  • days left to enroll
    58
  • participants needed
    18
  • sponsor
    Hebei Yanda Ludaopei Hospital
Updated on 24 January 2021

Summary

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.

Description

EBV infection is a common virus infection of HSCT, and which is highly related with the failure of transplantation and survival time of transplant patients. To evaluate the safety and efficacy of allogenic EBV-TCR-T cell therapy in subjects with EBV 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 0.1-1106 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).

Details
Condition EBV Emia and EBV Positive PTLD After Allogenic HSCT
Treatment EBV-TCR-T cells
Clinical Study IdentifierNCT04156217
SponsorHebei Yanda Ludaopei Hospital
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 1-70 years, including boundary values, gender unlimited
The EBV DNA copies number of allogenic HSCT patients with EBV infection (EBV emia and EBV positive PTLD) still did not decreaseafter treated with lower dosage of Immunosuppressantsor antiviral therapy or RituximabRituxan
Allogenic HSCT patients could not tolerate the antiviral therapy and / or RituximabRituxan
The EBV-positive diagnosis criteria: EBV DNA copy number>1000 copies/ ml, or the tissue EBV-EBER pathological result is positive, the diagnosis of PTLD was based on the diagnostic criteria of WHO 2016
Estimated life expectancy 3 months
ECOG 3
Patients who voluntarily sign informed consent and are willing to comply with treatment plans, visit arrangements, laboratory tests and other research procedures

Exclusion Criteria

Patients with active aGVHD III-IV and / or mild and severe cGVHD
Received cell therapy such as DLI,CTL,CAR-T or participated in any other clinical study of drugs and medical devices before 30 days of enrollment
Pregnant or lactating women
Intracranial hypertension or confusion; respiratory failure; disseminated intravascular coagulation
patients with organ failure
Heart: NYHA heart function grade IV
Liver: Grade C that achieves Child-Turcotte liver function grading
Kidney: kidney failure and uremia
Lung: symptoms of respiratory failure
Brain: a person with a disability
The researchers found that it was unsuitable for the recipients to be enrolled
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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