Clinical Study of EBV-TCR-T Cells for EBV-associated Hemophagocytic Lymphohistiocytosis or EBV Infection

Recruiting now · Phase 1

Conditions studied: EBV-associated Hemophagocytic Lymphohistiocytosis, EBV Infection

In brief

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-associated hemophagocytic lymphohistiocytosis (EBV-HLH) or EBV infection

Key facts

Study ID

NCT06135922

Run by

Chinese PLA General Hospital

People needed

9

Starts

2023-08-01

Expected to finish

2026-12-31

Last updated by the study team

2023-11-18

Who can join

Age: 1 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Chinese PLA General Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.