Actively Recruiting
Clinical Study of EBV-TCR-T Cells for EBV-associated Hemophagocytic Lymphohistiocytosis or EBV Infection
Led by Chinese PLA General Hospital · Updated on 2023-11-18
9
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Clinical Study of EBV-TCR-T Cells for EBV-associated Hemophagocytic Lymphohistiocytosis or EBV Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 1 to 60 years, any gender
- Diagnosed with EBV-associated hemophagocytic lymphohistiocytosis (HLH) or EBV infection
- Fully understand and agree to participate by signing informed consent
- Karnofsky Score 60; 70 if age 60; 16 years or Lansky Score 60; 50 if age < 16 years
- TCR-T cell donors must be at least 8 years old
- Donors must understand and voluntarily consent to participate and follow research procedures
- Donors must have at least a 3 out of 6 HLA match with recipients
- Donors must have lymphocyte counts between 0.8 to 4 f10^9/L
- Donors must have good venous access and no symptoms preventing blood cell collection
You will not qualify if you...
- Patients with uncontrolled active acute graft-versus-host disease (aGVHD) one day before TCR-T cell infusion
- Patients with severe kidney disease (Creatinine > 3 times normal)
- Patients with liver damage (total bilirubin > 2.5 times normal or ALT and AST > 3 times normal)
- Patients with heart failure (NYHA grade IV or left ventricular ejection fraction < 50%) one week before infusion
- Patients expected to take immunosuppressive hormones on the day of infusion
- Use of immunosuppressive drugs or G-CSF within 2 weeks before blood collection
- Patients with tumors or active uncontrolled malignant diseases
- Patients positive for HIV or TAP antibodies
- Pregnant or breastfeeding women
- Men and women of childbearing potential who refuse contraception during the study
- Patients expected to have other cell therapies within 4 weeks after infusion
- Participation in other clinical studies within 4 weeks before enrollment
- Allergy to albumin
- Donor exclusion: pregnant women
- Donors positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or TAP antibody
- Donors positive for EBV-DNA or CMV-DNA
- Donors with uncontrolled infections
- Donors who used immunosuppressive drugs or G-CSF within 2 weeks before blood collection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
Research Team
D
Daihong Liu, Doctor
CONTACT
L
Liping Dou, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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