Clinical trial NCT04156217: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: EBV Emia and EBV Positive PTLD After Allogenic HSCT
Lead sponsor: Hebei Yanda Ludaopei Hospital
Sponsor class: OTHER
Collaborators: name: China Immunotech (Beijing) Biotechnology Co., Ltd.
First posted: 2019-11-07
Enrollment: 18
Sex: ALL
Minimum age (years): 1
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of adverse events
timeFrame: 3months
Secondary outcomes:
measure: Proliferation ratio of TCR-T cells
timeFrame: 3months
measure: changes of EBV-DNA copies
timeFrame: 3months
Other outcomes:
Locations:
city: Sanhe
country: China
facility: Hebei Yanda Ludaopei Hospital
state: Hebei
Study officials:
References: