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

NCT04156217 | Completed Phase 1 DMC

• 1 other identifier: HXYT-004
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

EBV Emia and EBV Positive PTLD After Allogenic HSCT

Outcome Measures

Primary Outcomes (1)

• Percentage of adverse events

  Percentage of participants with adverse events.

  3months

Secondary Outcomes (2)

• Proliferation ratio of TCR-T cells

  3months

• changes of EBV-DNA copies

  3months

Study Arms (1)

EBV-TCR-T cells

EXPERIMENTAL

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).

Biological: EBV-TCR-T cells

Interventions

EBV-TCR-T cells BIOLOGICAL

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).

EBV-TCR-T cells

Eligibility Criteria

• Age: 1 Year - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hebei Yanda Ludaopei Hospital: lead
• China Immunotech (Beijing) Biotechnology Co., Ltd.: collaborator

Study Sites (1)

Hebei Yanda Ludaopei Hospital

Sanhe, Hebei, 065200, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 7, 2019
• Study Start: February 10, 2020
• Primary Completion: July 30, 2021
• Study Completion: October 31, 2021
• Last Updated: March 8, 2022

Record last verified: 2021-08

Locations

CN (1)