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New treatment option for Epstein-Barr Virus Infection
Official title Exploratory Study of EBV-TCR-T Cell Injection for EBV DNAemia After Allogeneic Hematopoietic Stem Cell Transplantation
ClinicalTrials.gov ID: NCT07368634
What this study is testing
What is EBV-TCR-T Cell Injection?
EBV-TCR-T Cell Injection is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for epstein-barr virus infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.