NCT07368634 Exploratory Study of EBV-TCR-T Cell Injection for EBV DNAemia After Allogeneic Hematopoietic Stem Cell Transplantation
| NCT ID | NCT07368634 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Daihong Liu |
| Condition | Epstein-Barr Virus Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2025-06-01 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Epstein-Barr virus (EBV) DNAemia is a common and potentially serious complication after allogeneic hematopoietic stem cell transplantation (allo-HSCT) and may progress to EBV-associated lymphoproliferative disorders. Current treatment options are limited, and effective immune-based therapies are still needed. This is an investigator-initiated, exploratory, open-label, single-arm clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of EBV-specific T cell receptor-engineered T cells (EBV-TCR-T cell injection) in patients with EBV DNAemia after allo-HSCT. Eligible participants will receive intravenous infusions of EBV-TCR-T cells at escalating dose levels. Safety outcomes, EBV-DNA clearance, and preliminary efficacy will be assessed, along with pharmacokinetic and pharmacodynamic characteristics of the infused cells.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years at the time of enrollment. * History of allogeneic hematopoietic stem cell transplantation. * Presence of Epstein-Barr virus (EBV) DNAemia confirmed by quantitative polymerase chain reaction (qPCR) in peripheral blood. * EBV DNAemia persisting or increasing despite standard management, as determined by the investigator. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Adequate organ function as defined by the study protocol. * Ability to understand and willingness to sign written informed consent. Exclusion Criteria: * Diagnosis of EBV-associated lymphoproliferative disorder requiring immediate cytotoxic chemotherapy. * Active, uncontrolled infection other than EBV. * History of severe autoimmune disease requiring systemic immunosuppressive therapy. * Uncontrolled graft-versus-host disease requiring high-dose systemic corticosteroids or other immunosuppressive treatment. * Prior treatment with EBV-specific adoptive T cell therapy within a defined washout period. * Known active malignancy other than EBV-related disease that may interfere with study participation. * Pregnant or breastfeeding women. * Any medical, psychological, or social condition that, in the opinion of the investigator, would interfere with safe participation in the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07368634 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Epstein-Barr Virus Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07368634 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07368634 currently recruiting?
Yes, NCT07368634 is actively recruiting participants. Contact the research team at daihongrm@163.com for enrollment information.
Where is the NCT07368634 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07368634 clinical trial?
NCT07368634 is sponsored by Daihong Liu. The trial plans to enroll 18 participants.