Clinical Study of EBV-TCR-T Cells for EBV-associated Hemophagocytic Lymphohistiocytosis or EBV Infection
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age1-60
SponsorChinese PLA General Hospital
About this trial
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 criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- EBV-TCR-T cells
Treatment groups
9 Participants
are divided into 1 treatment groupLocations
1Chinese PLA General Hospital100853, BeijingBeijing Municipality, China
Sponsors and collaborators
Chinese PLA General Hospital
Lead sponsor
Source ClinicalTrials.gov