Using EBV-TCR-T cells to treat EBV-related conditions

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 clinical study evaluates the safety and effectiveness of EBV-TCR-T cell immunotherapy for patients suffering from EBV-associated hemophagocytic lymphohistiocytosis or EBV infection. The study involves a multi-center, single-arm, open-label design where EBV-specific T cells are generated from donors and infused into patients at escalating doses. The primary focus is to assess the safety, efficacy, pharmacokinetics, and cytokine levels associated with this innovative treatment approach. Participants will be closely monitored to determine the therapeutic impact of the EBV-TCR-T cells.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 1-60 years, gender unlimited.
* Diagnosed with EBV associated-hemophagocytic lymphohistiocytosis (HLH) or EBV infection.
* Fully understood and informed the study and signed the ICF.
* Karnofsky Score ≥ 70(age ≥16y) or Lansky Score ≥ 50(age\<16y).
* TCRT-T cell donor inclusion criteria: 1)Age \>=8 years, gender unlimited; 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 or left ventricular ejection fraction\<50%) one week before TCR-T cell infusion.
* Anticipated to take immunosuppressive hormones on the day of TCR-T cell infusion.
* Use of immunosuppressive drugs or G-CSF within 2 weeks before PBMC blood collection.
* Have tumours, active and uncontrolled malignant diseases.
* Serologically positive for HIV-Ab or TAP-ab.
* Pregnant or lactating women.
* Men and their partners or women of childbearing potential refused contraception during the study period.
* 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 4 weeks of enrollment.
* Allergy to albumin.
* TCRT-T cell donor exclusion criteria: 1) pregnant woman; 2) Serologically positive for HBsAg, HCV-Ab, HIV-Ab or TAP-ab; 3) EBV-DNA or CMV-DNA positive; 4) other uncontrolled infection; 5) Use of immunosuppressive drugs or G-CSF within 2 weeks before PBMC blood collection.

Where it's running

• Chinese PLA General Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Daihong Liu, Doctor — Chinese PLA General Hospital
• Study coordinator: Daihong Liu, Doctor
• Email: daihongrm@163.com
• Phone: +86 18301339032

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Virus-specific T cells for kids after stem cell transplant

  This trial tests whether giving virus-specific T cells can safely help children with CMV, EBV, or BKV infections after a stem cell transplant.

  Recruiting LucasBio · Seoul · NCT07685457

• Multi-Virus Specific T cells for antiviral-resistant CMV, BKV, or EBV after cancer therapy or stem cell transplant

  This trial tests LB-DTK-MV cells to see if they safely reduce CMV, BKV, or EBV in patients who have antiviral-resistant infections after cancer treatment or stem cell transplant.

  Recruiting Phase 1/2 LucasBio · Seoul · NCT07670468

• Valacyclovir versus valganciclovir to prevent CMV and EBV after kidney transplant

  This test checks whether valacyclovir works as well as valganciclovir to prevent CMV and EBV in people who recently had a kidney transplant.

  Recruiting National Taiwan University Hospital · Taipei · NCT07294547

• T-cell therapy for viral infections after stem cell transplant

  This study is testing whether giving special T-cells that target specific viruses can help patients who have had a stem cell transplant and are struggling with tough viral infections.

  Recruiting at 33 sites Phase 3 University Hospital Freiburg · Brussels and 32 other locations · NCT04832607

• Evaluating 2LEBV® and 2LXFS® for fatigue in Epstein-Barr Virus patients

  This study is testing two new medications to see if they can help people aged 12 and older who have been feeling very tired due to Epstein-Barr Virus infections.

  Recruiting at 7 sites Phase 4 Labo'Life · Heule, Kortrijk and 7 other locations · NCT04308278

• Tracking outcomes of chronic EBV infection

  This study is tracking people with high levels of Epstein-Barr virus in their blood to see if it leads to blood cancers and to understand how the virus might affect the immune system.

  Recruiting Huazhong University of Science and Technology · Wuhan, Hubei · NCT03491605

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.