EBV-associated lymphomas and chronic active EBV disease EBV-associated lymphomas, chronic active EBV disease
Conditions
Interventions
rejT-E01 administration
Sponsors
Ando Miki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with EBV-associated lymphoproliferative disorders or chronic active EBV disease 2)Patients with Performance Status 0 to 1 as defined by the Eastern Cooperative Oncology Group (ECOG) 3)Patients between 20 and 70 years old at the time of enrollment in the study 4)Patients with relapsed or refractory EBV-associated lymphoproliferative disorders or chronic active EBV disease who did not respond to standard therapy or experienced recurrence after treatment 5)Patients who have HLA-A*2402 by HLA-A, B, C, and DRB1 locus genotyping 6)Patients with no serious organ dysfunction or serious bleeding tendency and who meet all of the following laboratory criteria Creatinine = 500 /uL (patients with bone marrow suppression due to lymphoma who are expected to recover may be included) Platelet count >= 20,000 /uL (patients with bone marrow suppression due to lymphoma may be included) Blood oxygen saturation >= 93% (on room air) 7)Patients who comprehend the nature of the treatment and can provide written informed consent of their own free will
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study 1)Patients with severe cardiac disease 2)Patients with a history of severe cerebrovascular disease or with sequelae such as paralysis resulting from it 3)Patients with active or severe infections (excluding EBV infection) 4)Patients who are HIV antibody positive 5)Patients who are HBs antigen positive, or HBc antibody positive with detectable HBV-DNA 6)Patients with active HCV infection 7)Patients with psychiatric disorders, drug dependency, or other conditions that may interfere with their ability to consent to the study 8)Pregnant or breastfeeding women; women who may be pregnant; or women who wish to become pregnant during the study period 9)Women of childbearing potential who are unwilling to use highly effective contraception from the time of consent through 12 months after the last administration of rejT-E01 10)Patients with a history of hypersensitivity to animal-derived products (bovine, porcine, rodent) used in the manufacturing process of rejT-E01 11)Any other condition deemed inappropriate for participation in the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability 1.Incidence of adverse events, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 2.Laboratory test abnormalities and assessment of cytokine release syndrome (CRS), graded according to the ASTCT (American Society for Transplantation and Cellular Therapy) Consensus Grading of CRS 3.Neurotoxicity (ICANS), assessed according to standard diagnostic criteria 4.Severity of graft-versus-host disease (GvHD), graded according to the 4th edition of the Japanese Hematopoietic Cell Transplantation Guidelines for GvHD | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Progression-free survival (PFS) 2.Tumor response assessment based on the revised Lugano Classification 3.Kinetics of plasma EBV DNA levels | — |
Contacts
Public ContactJun Ando
Juntendo University School of Medicine
Outcome results
None listed