Clinical Study of EBV-TCR-T Cells for EBV Infection After Allogenic HSCT
ConditionEBV Infection After Allogenic HSCT
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age14-75
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 virus infection after allogenic HSCT.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 14-75 years, gender unlimited.
Diagnosed with hematologic malignancies and have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), with EBV infection after allo-HSCT.
Karnofsky Score ≥ 70(age ≥16y) or Lansky Score ≥ 50(age<16y).
TCR-T cell donor inclusion criteria: 1) Age 8-70 years; 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.
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) one week before TCR-T cell infusion.
Anticipated to take immunosuppressive hormones on the day of TCR-T cell infusion.
Have other malignancies.
Trial design
Design model
Single group
Treatments tested in this trial
EBV-TCR-T cells
Biological/VaccineThe patients with EBV infection after HSCT will receive one to three infusions of donor-derived EBV-TCR-T cells, with the escalated dose ranging from 5×10\^5/kg to 1×10\^6/kg EBV-TCR-T cells per dose.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: 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
Changes of EBV-DNA copies number
Quantitative PCR will be used to determine viral copy numbers in peripheral blood.
Time frame
1 year after EBV-TCR-T treatment2
Persistence of EBV-TCR-T cells
Quantitative PCR using primers specific for the gene encoding EBV-TCR will be used to determine the number of circulating EBV-TCR-T cells in peripheral blood post infusion.
Time frame
1 year after EBV-TCR-T treatment3
Dose-limiting toxicity
Toxic effects considered by the investigators to be related to the EBV-TCR-T
Time frame
28 days after EBV-TCR-T treatment4
Maximum tolerated dose
The highest dose of DLT was seen in 1/6 of the subjects
Time frame
28 days after EBV-TCR-T treatmentSponsors and contacts
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Source ClinicalTrials.gov