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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
EBV-TCR-T cells
Biological/VaccineThe 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.
Treatment groups
9 Participants
are divided into 1 treatment groupGroup A: Experimental: EBV-TCR-T cellsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse events
Percentage of participants with adverse events
Time frame
1 year after EBV-TCR-T treatmentSecondary outcomes
1
Dose-limiting toxicity (DLT)
Toxic effects considered by the investigators to be related to the EBV-TCR-T
Time frame
28 days after EBV-TCR-T treatment2
Maximum tolerated dose （MTD）
The highest dose of DLT was seen in 1/6 of subjects
Time frame
28 days after EBV-TCR-T treatment3
The proportion of EBV-DNA negative patients
The proportion of patients EBV-DNA negative after EBV-TCR-T treatment
Time frame
180 days after EBV-TCR-T treatment4
The time to EBV-DNA negative
The time from the start of therapy to EBV-DNA negative detected
Time frame
180 days after EBV-TCR-T treatmentSponsors and contacts
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Source ClinicalTrials.gov