Clinical Study of EBV-TCR-T Cells for EBV Infection After Allogenic HSCT

March 29, 2026 updated by: Daihong Liu, Chinese PLA General Hospital

Multicenter, Open Label, Single-arm Exploratory Clinical Study of EBV-TCR-T Cells for EBV Infection After Allogenic HSCT

This is a multi-center, single arm, open-label, phase I study to determine the safety and effectiveness of EBV-TCR-T cell immunotherapy in treating EBV virus infection after allogenic HSCT.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

EB virus (EBV) infection after allogeneic hematopoietic stem cell transplantation (HSCT) is common and can be lethal without prompt treatment. In this prospective study, HLA-A*02:01/11:01/24:02-restricted EBV-specific T cell receptor (TCR) will be introduced into the T cells of HSCT donors by ex vivo lentiviral transduction to generate EBV-TCR-T cells. An escalated dose ranging from 3×10^5/kg to 1×10^6/kg of EBV-TCR-T cells will be infused into patients with EBV infection. The safety, efficacy, pharmacokinetics and cytokine levels of allogenic EBV-TCR-T cell therapy will be evaluated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Liping Dou, Doctor
  • Phone Number: +86 13681207138

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100853
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daihong Liu, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 14-75 years, gender unlimited.
  • Diagnosed with hematologic malignancies and have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), with EBV infection after allo-HSCT.
  • Karnofsky Score ≥ 70(age ≥16y) or Lansky Score ≥ 50(age<16y).
  • TCR-T cell donor inclusion criteria: 1) Age 8-70 years; 2) Understand and voluntarily sign informed consent and are willing to comply with laboratory tests and other research procedures; 3) ≥ 3/6 HLA match with TCR-T cell recipients enrolled; 4) Lymphocyte count = (0.8~4) × 10^9/L; 5) Have sufficient venous circulation, without any symptoms that do not allow blood cell isolation.

Exclusion Criteria:

  • Patients with uncontrolled active aGVHD one day before TCR-T cell infusion.
  • Patients with severe kidney disease (Cr > 3×normal value), liver damage (TBIL >2.5×upper limit of normal value, ALT and AST > 3×upper limit of normal value) or heart failure (NYHA heart function grade IV) one week before TCR-T cell infusion.
  • Anticipated to take immunosuppressive hormones on the day of TCR-T cell infusion.
  • Have other malignancies.
  • Have relapsed and uncontrolled hematologic malignancies.
  • Serologically positive for HIV-Ab or TAP-ab.
  • Pregnant or lactating women.
  • Anticipated to have other cell therapies in 4 week post TCR-T cell infusion.
  • Participated in any other clinical study of drugs and medical devices before 30 days of enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EBV-TCR-T cells

Phase 1 trail:

The patients with EBV infection after HSCT will receive one to three infusions of donor-derived EBV-TCR-T cells, with the escalated dose ranging from 5×10^5/kg to 1×10^6/kg EBV-TCR-T cells per dose.

Phase 2 trail:

According to the PK and response data, the dose escalation phase will be carried out.
Biological: EBV-TCR-T cells
The patients with EBV infection after HSCT will receive one to three infusions of donor-derived EBV-TCR-T cells, with the escalated dose ranging from 5×10^5/kg to 1×10^6/kg EBV-TCR-T cells per dose.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 1 year after EBV-TCR-T treatment
Percentage of participants with adverse events.
1 year after EBV-TCR-T treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes of EBV-DNA copies number
Time Frame: 1 year after EBV-TCR-T treatment
Quantitative PCR will be used to determine viral copy numbers in peripheral blood.
1 year after EBV-TCR-T treatment
Persistence of EBV-TCR-T cells
Time Frame: 1 year after EBV-TCR-T treatment
Quantitative PCR using primers specific for the gene encoding EBV-TCR will be used to determine the number of circulating EBV-TCR-T cells in peripheral blood post infusion.
1 year after EBV-TCR-T treatment
Dose-limiting toxicity
Time Frame: 28 days after EBV-TCR-T treatment
Toxic effects considered by the investigators to be related to the EBV-TCR-T
28 days after EBV-TCR-T treatment
Maximum tolerated dose
Time Frame: 28 days after EBV-TCR-T treatment
The highest dose of DLT was seen in 1/6 of the subjects
28 days after EBV-TCR-T treatment
The proportion of EBV-DNA negative patients
Time Frame: 180 days after EBV-TCR-T treatment
The proportion of patients EBV-DNA negative after EBV-TCR-T treatment
180 days after EBV-TCR-T treatment
The time to EBV-DNA negative
Time Frame: 180 days after EBV-TCR-T treatment
The time from the start of therapy to EBV-DNA negative detected
180 days after EBV-TCR-T treatment
The time to response
Time Frame: 180 days after EBV-TCR-T treatment
The time from the start of therapy to the time when patients firstly achieve complete remission or partial remission
180 days after EBV-TCR-T treatment
The duration of response
Time Frame: 1 year after EBV-TCR-T treatment
The time from the patients firstly achieve complete remission or partial remission to progression of disease
1 year after EBV-TCR-T treatment
The incidence of EBV-PTLD
Time Frame: 1 year after EBV-TCR-T treatment
The incidence of EBV-PTLD after EBV-TCR-T treatment
1 year after EBV-TCR-T treatment
The overall response rate to EBV-TCR-T treatment
Time Frame: 28,90,180,365,730 days after EBV-TCR-T treatment
The overall response rate to EBV-TCR-T treatment
28,90,180,365,730 days after EBV-TCR-T treatment
The complete response rate to EBV-TCR-T treatment
Time Frame: 28,90,180,365, and 730 days after EBV-TCR-T treatment
The complete response rate to EBV-TCR-T treatment
28,90,180,365, and 730 days after EBV-TCR-T treatment
The incidence of EBV reactivation after EBV-TCR-T treatment
Time Frame: 1 year after EBV-TCR-T treatment
The incidence of EBV reactivation after EBV-TCR-T treatment
1 year after EBV-TCR-T treatment
Maximum Plasma Concentration (Cmax) of EBV-TCR-T cells
Time Frame: 28 days after EBV-TCR-T treatment
Pharmacokinetic (PK) parameters of EBV-TCR-T cells in patients with EBV reactivation
28 days after EBV-TCR-T treatment
Area under the plasma concentration versus time curve (AUC) of EBV-TCR-T cells
Time Frame: 28 days after EBV-TCR-T treatment
Pharmacokinetic (PK) parameters of EBV-TCR-T cells in patients with EBV reactivation
28 days after EBV-TCR-T treatment
Half life time (T1/2) of EBV-TCR-T cells
Time Frame: 28 days after EBV-TCR-T treatment
Pharmacokinetic (PK) parameters of EBV-TCR-T cells in patients with EBV reactivation
28 days after EBV-TCR-T treatment
Concentration levels of cytokines
Time Frame: 28 days after EBV-TCR-T treatment
Concentration levels of cytokines (IL-2, IL-6, IL-10, TNF-α, IFN-γ)
28 days after EBV-TCR-T treatment
Concentration levels of CRP
Time Frame: 28 days after EBV-TCR-T treatment
Pharmacokinetics of EBV-TCR-T cells
28 days after EBV-TCR-T treatment
Concentration levels of ferritin
Time Frame: 28 days after EBV-TCR-T treatment
Pharmacokinetics of EBV-TCR-T cells
28 days after EBV-TCR-T treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese PLA General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daihong Liu, Doctor, Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S2022-083-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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