RecruitingPhase 1NCT06135922

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

Multicenter, Open Label, Single-arm Exploratory Clinical Study of EBV-TCR-T Cells for EBV-associated Hemophagocytic Lymphohistiocytosis or EBV Infection

Sponsor

Chinese PLA General Hospital

Enrollment

9 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

EBV Infection EBV-associated Hemophagocytic Lymphohistiocytosis

Summary

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

Eligibility

Min Age: 1 YearMax Age: 60 Years

Inclusion Criteria4

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).

Exclusion Criteria11

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.

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Interventions

BIOLOGICALEBV-TCR-T cells

The patients with EBV-HLH or EBV infection will receive infusions of EBV-TCR-T cells, with the escalated dose ranging from 1×10\^6/kg to 1×10\^8/kg EBV-TCR-T cells per dose.