Using engineered T cells to treat EBV infection after stem cell transplant

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

This study is testing a new treatment using specially modified T cells to help patients who have developed Epstein-Barr virus infection after a stem cell transplant.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 14 Years to 75 Years
• Sex: All
• Sponsor: Chinese PLA General Hospital (other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06119256 on ClinicalTrials.gov

What this trial studies

This phase I clinical study aims to evaluate the safety and effectiveness of EBV-TCR-T cell immunotherapy for patients who have developed Epstein-Barr virus (EBV) infection following allogeneic hematopoietic stem cell transplantation (HSCT). The approach involves genetically modifying T cells from HSCT donors to express a specific T cell receptor that targets EBV. Patients will receive escalating doses of these engineered T cells to determine the optimal dosage while monitoring safety, efficacy, and immune response. The study is conducted at a single center, focusing on a population at high risk for severe EBV-related complications.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 14-75 who have undergone allogeneic HSCT and are diagnosed with EBV infection.

Not a fit: Patients with uncontrolled active graft-versus-host disease or severe organ dysfunction may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from EBV infections after stem cell transplants.

How similar studies have performed: While this approach is innovative, similar studies targeting viral infections post-transplant have shown promise, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* 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.

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) one week before TCR-T cell infusion.
* Anticipated to take immunosuppressive hormones on the day of TCR-T cell infusion.
* Have other malignancies.
* Have relapsed and uncontrolled hematologic malignancies.
* Serologically positive for HIV-Ab or TAP-ab.
* Pregnant or lactating women.
* 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.

Where this trial is running

Beijing, Beijing Municipality

• 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

Conditions: EBV Infection After Allogenic HSCT, EBV infection, allogenic HSCT