Back to resultsEBV-TCR-T Cells for EB Virus Infection After HSCT
Primary Purpose
EBV Emia and EBV Positive PTLD After Allogenic HSCT
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
EBV-TCR-T cells
Sponsored by
About this trial
This is an interventional treatment trial for EBV Emia and EBV Positive PTLD After Allogenic HSCT
Eligibility Criteria
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 decrease，after treated with lower dosage of Immunosuppressants，or antiviral therapy or Rituximab（Rituxan）；
- Allogenic HSCT patients could not tolerate the antiviral therapy and / or Rituximab（Rituxan）；
- 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.
Sites / Locations
- Hebei Yanda Ludaopei Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EBV-TCR-T cells
Arm Description
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).
Outcomes
Primary Outcome Measures
Percentage of adverse events
Percentage of participants with adverse events.
Secondary Outcome Measures
Proliferation ratio of TCR-T cells
changes of EBV-DNA copies
Full Information
NCT ID
NCT04156217
First Posted
November 4, 2019
Last Updated
March 6, 2022
Sponsor
Hebei Yanda Ludaopei Hospital
Collaborators
China Immunotech (Beijing) Biotechnology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04156217
Brief Title
EBV-TCR-T Cells for EB Virus Infection After HSCT
Official Title
A Pilot Study of EBV-TCR-T Cells in EB Virus Infection Diseases After HSCT
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Yanda Ludaopei Hospital
Collaborators
China Immunotech (Beijing) Biotechnology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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 0.1-1×106 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
EBV Emia and EBV Positive PTLD After Allogenic HSCT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EBV-TCR-T cells
Arm Type
Experimental
Arm Description
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).
Intervention Type
Biological
Intervention Name(s)
EBV-TCR-T cells
Intervention Description
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).
Primary Outcome Measure Information:
Title
Percentage of adverse events
Description
Percentage of participants with adverse events.
Time Frame
3months
Secondary Outcome Measure Information:
Title
Proliferation ratio of TCR-T cells
Time Frame
3months
Title
changes of EBV-DNA copies
Time Frame
3months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 decrease，after treated with lower dosage of Immunosuppressants，or antiviral therapy or Rituximab（Rituxan）；
Allogenic HSCT patients could not tolerate the antiviral therapy and / or Rituximab（Rituxan）；
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.
Facility Information:
Facility Name
Hebei Yanda Ludaopei Hospital
City
Sanhe
State/Province
Hebei
ZIP/Postal Code
065200
Country
China
12. IPD Sharing Statement
Learn more about this trial
EBV-TCR-T Cells for EB Virus Infection After HSCT
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