Using EBV-TCR-T cells to treat EBV-related conditions
Multicenter, Open Label, Single-arm Exploratory Clinical Study of EBV-TCR-T Cells for EBV-associated Hemophagocytic Lymphohistiocytosis or EBV Infection
This study is testing a new treatment using special immune cells to see if it can help people with serious conditions related to the Epstein-Barr virus.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 9 (estimated) |
| Ages | 1 Year to 60 Years |
| Sex | All |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06135922 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 1-60 years diagnosed with EBV-associated hemophagocytic lymphohistiocytosis or 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 provide a novel therapeutic option for patients with severe EBV-related conditions.
How similar studies have performed: While this approach is innovative, similar studies using TCR-T cell therapy have shown promise in treating other viral infections and malignancies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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
- Email: daihongrm@163.com
- Phone: +86 18301339032
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.