EBV-targeted T-cell therapy for persistent EBV DNAemia after allogeneic transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, single-arm dose-escalation trial administers EBV-specific TCR-engineered T cells manufactured from the patient or an appropriate donor via intravenous infusion. Participants may receive up to three weekly infusions at escalating dose levels (1×10^5, 5×10^5, 1×10^6 cells/kg) with dose escalation guided by predefined dose-limiting toxicities to identify a tolerated or optimal biologic dose. Key outcomes include safety, adverse events, EBV DNA clearance, and pharmacokinetic/pharmacodynamic profiling of the infused cells. The study plans to enroll approximately 4–18 adults with EBV DNAemia after allo-HSCT at a single center.

Why it matters

Who can join: the full rules

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.

Where it's running

• Chinese PLA General Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Daihong Liu
• Email: daihongrm@163.com
• Phone: +8613681171597

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.