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NCT06119256RecruitingPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 2 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
12 (estimated)
First submitted
21 Oct 2023
Start date
1 Aug 2023
Primary completion date
31 Dec 2027
Lead sponsor
Chinese PLA General Hospital
NCT number
NCT06119256

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 12
  • From 1 Aug 2023 to the primary completion date, 31 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with uncontrolled active aGVHD one day before TCR-T cell infusion.
  • 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.

Other illness

  • Have other malignancies.
  • Have relapsed and uncontrolled hematologic malignancies.
  • Serologically positive for HIV-Ab or TAP-ab.

Lab values

  • 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.

Other

  • Anticipated to take immunosuppressive hormones on the day of TCR-T cell infusion.
  • Pregnant or lactating women.

Who the study is looking for

  • 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.

Age in the registry: 14 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chinese PLA General Hospital
Coordinator of this site? Confirm its status
BeijingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.