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

EBV Emia and EBV Positive PTLD After Allogenic HSCT Clinical Trial

Official title:

A Pilot Study of EBV-TCR-T Cells in EB Virus Infection Diseases After HSCT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04156217
• Other study ID #: HXYT-004
• Status: Completed
• Phase: Phase 1
• Start date: February 10, 2020
• Est. completion date: October 31, 2021

Study information

• Verified date: August 2021
• Source: Hebei Yanda Ludaopei Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 0.1-1×106 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 31, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 70 Years

Eligibility

Inclusion Criteria:

1. Age 1-70 years, including boundary values, gender unlimited;

2. 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);

3. Allogenic HSCT patients could not tolerate the antiviral therapy and / or Rituximab(Rituxan);

4. 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;

5. Estimated life expectancy = 3 months;

6. ECOG 3 ;

7. Patients who voluntarily sign informed consent and are willing to comply with treatment plans, visit arrangements, laboratory tests and other research procedures.

Exclusion Criteria:

1. Patients with active aGVHD III-IV and / or mild and severe cGVHD;

2. 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;

3. Pregnant or lactating women;

4. Intracranial hypertension or confusion; respiratory failure; disseminated intravascular coagulation;

5. 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;

6. The researchers found that it was unsuitable for the recipients to be enrolled.

Related Conditions & MeSH terms

• EBV Emia and EBV Positive PTLD After Allogenic HSCT
• Virus Diseases

Intervention

Biological:
• EBV-TCR-T cells
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).

Locations

Country	Name	City	State
China	Hebei Yanda Ludaopei Hospital	Sanhe	Hebei

Sponsors (2)

Lead Sponsor	Collaborator
Hebei Yanda Ludaopei Hospital	China Immunotech (Beijing) Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of adverse events	Percentage of participants with adverse events.	3months
Secondary	Proliferation ratio of TCR-T cells		3months
Secondary	changes of EBV-DNA copies		3months